Oncology News & Updates

FDA Approvals

On May 5, 2024, (FDA) Oncology Center of Excellence (OCE) launched the Project 5 in 5 crowdsourcing initiative.

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On May 16, 2024, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

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On May 29, 2024, the FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older.

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National Guideline Updates

View the NCCN eBulletin Here

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia. These NCCN Guidelines® are currently available as Version 3.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cervical Cancer. These NCCN Guidelines® are currently available as Version 3.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Gastric Cancer. These NCCN Guidelines®are currently available as Version 2.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), the NCCN Drugs & Biologics Compendium (NCCN Compendium®), the NCCN Radiation Therapy Compendium™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Pediatric Hodgkin Lymphoma. These NCCN Guidelines® are currently available as Version 1.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer. These NCCN Guidelines® are currently available as Version 4.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Appendiceal Adenocarcinoma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer v2.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Head and Neck Cancers to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Head and Neck Cancers v4.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Melanoma: Cutaneous to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma: Cutaneous v2.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer v2.2024.

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ASCO in Action

Expanded Oncology Summer Internship Program Targets Increased Workforce Diversity.

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Medicare Fee Schedule Updates Enable Reimbursement for Patient Navigation, Learn More in Free Webinar.

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Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here

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Other

View the AACR Cancer Disparities Progress Report 2024 Congressional Briefing

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View the AACR Cancer Disparities Progress Report 2024

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View the May 2024 ASH Practice Update

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FDA Approvals

On April 5, 2024, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.).

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On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.)

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On April 26, 2024, the Food and Drug Administration issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.

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On April 29, 2024, the Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]).

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National Guideline Updates

Check out the NCCN Calendar of Events:

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Esophageal and Esophagogastric Junction Cancers.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hairy Cell Leukemia

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Biliary Tract Cancers to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Biliary Tract Cancers v1.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma v3.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Non-Small Cell Lung Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v5.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Rectal Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer v1.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for T- Cell Lymphomas to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for T-Cell Lymphomas v3.2024

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for T-cell Large Granular Lymphocytic Leukemia and T-Cell Prolymphocytic Leukemia to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for T-Cell Lymphomas V.3.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Multiple Myeloma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma v3.2024.

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Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here

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Other

On April 10, 2024 Takeda Announces EXKIVITY (mobocertinib) Is No Longer Commercially Available in U.S. Market.

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View Noridian Medicare Jurisdiction E Part B Updates.

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FDA Approvals

On March 7, 2024, the Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene USA, Inc.) with Obinutuzumab.

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On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy.

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Pfizer Oncology is proud to announce the FDA approval of a new pediatric indication for BESPONSA® (inotuzumab ozogamicin).

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On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products.

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On March 22, 2024, the Food and Drug Administration approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [now a part of AbbVie]).

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National Guideline Updates

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Bladder Cancer.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer Screening and Diagnosis.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), the NCCN Drugs & Biologics Compendium (NCCN Compendium®), the NCCN Radiation Therapy Compendium™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Gastric Cancer.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Breast Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer v2.2024

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Head and Neck Cancers to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Head and Neck Cancers v3.2024.

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ASCO News

View ASCO Daily News Here:

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Practices, Providers Face Uncertainty Following Change Healthcare Ransomware Attack.

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Cancer Care Providers Applaud Final Rule to Strengthen Health Insurance Standards.

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New ASCO Guideline Recommendations Answer Key Questions About Vaccinating Adults with Cancer.

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Congress to Finalize Cancer Research Funding Levels for FY 2024.

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2024 Medicare Provider Conversion Factor Updated to Reflect Federal Spending Legislation.

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New ASCO Policy Statement Calls for Global Equity in Cancer Clinical Trials.

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CMA News

View California Medical Association Newswire here:

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Please share your feedback on Change Healthcare cyberattack: Deadline extended to April 3.

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Reminder: Optum offering temporary funding assistance for providers affected by cyberattack.

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Biden Administration announces advanced payments for physicians affected by cyberattack.

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New York Times video on prior authorization spotlights CMA physicians and California patients.

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CMS reopens MIPS Extreme/Uncontrollable Circumstances exception application due to cyberattack.

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Final federal spending bills allow half of 3.37% Medicare cut to remain in effect.

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CMS releases updated fee schedule conversion factor.

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CMS & Noridian Updates

Billing and Coding: MolDX: Proteomics Testing (A59641) – R2 – Effective January 31, 2024.

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MolDX: NRAS Genetic Testing (L36335) – R7 – Effective July 27, 2023.

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Optum, the parent company for Change Healthcare, has worked with Noridian to transition providers enrolled in Change Healthcare connections to the Optum iEDI Clearinghouse.

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Read MLNC Newsletter here:

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View CMS Medicare Learning Network (MLN) Matters (MM) New Waived Tests:

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View CMS Medicare Learning Network (MLN) Matters (MM) Stay of Enrollment:

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Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here:

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View Breaking News Optum/Change Outage Update Here:

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Other

Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer. KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.

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FDA Approvals

On December 5, 2023, the US Food and Drug Administration (FDA) approved FABHALTA® (iptacopan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).1,2

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On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.

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On February 15, 2024, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

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On February 16, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

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Treatment for Adult Patients With Locally Advanced or Metastatic Urothelial Cancer KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

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National Guideline Updates

NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Non-Small Cell Lung Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v1.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), the NCCN Radiation Therapy Compendium™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Acute Myeloid Leukemia. These NCCN Guidelines® are currently available as Version 1.2024.

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Coding and Reimbursement Updates

View the February E-Reimbursement Newsletter.

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Other

View the ASCO in Action February newsletter.

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ImmunoGen, Inc. is now part of AbbVie, Inc. The acquisition of ImmunoGen is a transformative move for AbbVie and advances the AbbVie mission to make a remarkable impact on patients’ lives and enhance our value as a long-term partner to those who share our vision for solving serious health issues.

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On behalf of Merck, read more about the update regarding TICE® BCG BCG LIVE (for intravesical use) (“TICE BCG”).

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FDA Approvals

On January 12, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.

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On January 19, 2024, the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.

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The FDA has granted full approval to KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with enfortumab vedotin, and expanded the indication to: treatment of adult patients with locally advanced or metastatic urothelial cancer. The combination initially received accelerated approval in April 2023 for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

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The FDA has approved WELIREG® (belzutifan) 40-mg tablets for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

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Coding and Reimbursement Updates

View the January E-Reimbursement Newsletter.

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CMS & Noridian Updates

CMS has finalized the Interoperability and Prior Authorization “e-PA” Rule requiring MA plans to establish electronic PA systems. Starting in 2026 MA plans must send PA decisions within 72 hours for expedited requests and 7 days for standard requests, detail a specific reason for denying a PA appeal, and report PA metrics as part of new transparency and reporting requirements. This rule impacts MA, Medicaid, CHIP, Medicare, and ERISA plans. This rule does not require HHS to establish a list of items/services eligible for real-time decisions as in Seniors’ Act.

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Governor Gavin Newsom and the State of California received federal approval from the Centers for Medicare & Medicaid Services (CMS) of its MCO tax federal waiver application. Effective January 1, 2024, rates for primary care (including nurse practitioners and physician assistants), maternity care (including OB/GYNs and doulas), and non-specialty mental health services will be increased to at least 87.5 percent of Medicare rates.

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National Guideline Updates

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas. These NCCN Guidelines® are currently available as Version 1.2024.

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Other

View the ASCO in Action January newsletter.

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Register for Bristol Myers Squibb’s, “A Treatment Option for Patients with Unresectable or Metastatic Melanoma regardless of BRAF status & Metastatic NSCLC Regardless of PD-L1 Expression” on Wednesday, February 28, 2024 at 6:30 PM – PST.

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FDA Approvals

On November 15, 2023, the Food and Drug Administration approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.

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On November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).

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On November 16, 2023, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. FDA also approved the FoundationOne®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.

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On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

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On December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

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On December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy.

Full prescribing information for Padcev and Keytruda will be posted here.

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Merck would like to inform you that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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Merck would like to inform you that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

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Updated indication treatment for patients with recurrent locally advanced or Metastatic Merkel Cell Carcinoma (MCC). KEYTRUDA® (pembrolizumab) Injection 100 mg is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic MCC.

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The U.S. Food and Drug Administration has approved of PADCEV + pembrolizumab for the treatment of adult patients with locally advanced or mUC based on data from the EV-302 trial. This latest approval expands the indication of PADCEV + pembrolizumab and the patient population that may benefit from this treatment.

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National Guideline Updates

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), for Prevention and Treatment of Cancer Related Infections. These NCCN Guidelines® are currently available as Version 2.2023.

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Other

This notification is being provided to update you on the official withdrawal of EXKIVITY (mobocertinib), which will occur no later than March 2024, with the specific date still to be determined by the US Food and Drug Administration (FDA) based on review of ongoing operational activities related to the withdrawal. Until withdrawal, EXKIVITY continues to be available to prescribe for patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy.

 

Patients receiving EXKIVITY will be able to maintain access following withdrawal from the market through a compassionate use program that is being established. After withdrawal, the compassionate use program will provide prescribed patients access to EXKIVITY free of charge for as long as they are benefiting from the medication, as assessed by their HCP. However, EXKIVITY will no longer be available for new patients following withdrawal from the market, which will occur no later than March 2024.

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Register for Clinical Care Solutions webinar, “A Treatment Option for ROS1+ NSCLC”, on Wednesday January 17, 2024 from 12:15 – 12:45 pm ET. Join a leading oncology expert to discuss recent clinical data for the application of an emerging treatment for ROS1-positive NSCLC.​

View the invitation at the link below for more information.

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CMS & Noridian Updates

Medicare Jurisdiction E Part B Updates

• Payment of Codes for Chemotherapy Administration and Nonchemotherapy Injections and Infusions CR13468
  • CR 13468 provides clarification regarding the Medicare guidance/policy that relates to CPT codes 96401-96549. Read the complete update here.
• January 2024 Quarterly ASP Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files CR13380
  • CR 13380 supplies the contractors with the ASP and NOC drug pricing files.

State and National Legislative & Regulatory Issues

Read the latest CMA practice resources newsletter.

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Northern California Clinical Trials

List of newly available adjuvant trials for patients with high-risk melanoma at UCSF:

 

1. A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001). This is a personalized neoantigen mRNA vaccine trial that randomizes patients with stage IIB-IV melanoma s/p surgery to either the vaccine and pembro or pembro alone in a 2:1 ratio. Data from a smaller trial has been presented at ASCO and ESMO recently showing benefit.
2. Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010). Vibostolimab is a TIGIT antibody and in a prior trial appeared beneficial in the neoadjuvant setting.
3. Adjuvant Fianlimab plus Cemiplimab versus cemiplimab in Resected High-Risk Stage II-IV Melanoma. Fianlimab is a Lag-3 antibody and this trial randomizes patients to this combination versus cemiplimab alone (PD-1 antibody).

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FDA Approvals

Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo®(nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for melanoma patients. The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).

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US Food and Drug Administration has approved FRUZAQLA™ (fruquintinib), an oral therapy for adult patients with previously treated metastatic colorectal cancer (mCRC).

FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with mCRC who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.

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On November 7, 2023, the Food and Drug Administration revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test.

The FDA also approved the Agilent PD-L1 IHC 22C3 pharmDx as a companion diagnostic device to select patients with gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1).

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On November 8, 2023, the Food and Drug Administration approved fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) for adult patients with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

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On November 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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NCCN Updates

An option for the first-line treatment of certain adult patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible recommended by the National Comprehensive Cancer Network® (NCCN®)

KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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NCCN Guidelines Updated for Non-Small Cell Lung Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs and Biologics Compendium (NCCN Compendium®) for Non-Small Cell Lung Cancer. These NCCN Guidelines® are currently available as Version 5.2023.

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NCCN Guidelines Updated

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Colon Cancer. These NCCN Guidelines® are currently available as Version 4.2023.

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Coding and Reimbursement Updates

View the November E-Reimbursement Newsletter

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BREAKING E-Reimbursement News: Q1 Mega HCPCS, Split Visits, SDoH, and Payer Shenanigans 11-30-2024

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Other

Treatment for Patients With Resectable (Tumors ≥4 cm or Node Positive) Non–Small Cell Lung Cancer (NSCLC) KEYTRUDA® (pembrolizumab) Injection 100 mg is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

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State and National Legislative & Regulatory Issues

ASCO Research Statement Recommends Cancer Clinical Trials Provide A Way To Assess Ovarian Toxicity

Healio (10/3, Shinkle) reports, “ASCO released a research statement outlining new recommendations regarding the appropriate assessment of ovarian toxicity in cancer clinical trials.” The new “statement’s three key recommendations aim to provide researchers with a way to measure ovarian toxicity in cancer clinical trials while also encouraging data acquisition.” According to Healio, “The goal is to provide patients and clinicians with information regarding potential long-term effects of certain treatments.” The statement was published in The Lancet Oncology.

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FDA Approvals

On October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

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On October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted accelerated approval to entrectinib for pediatric patients 12 years of age and older for this indication.

FDA also approved a new oral pellet formulation for entrectinib, and the prescribing information now includes instructions for making an oral suspension from the capsules.

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On October 27, 2023, the Food and Drug Administration approved toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

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Coding and Reimbursement Updates

View the August E-Reimbursement Newsletter

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The Centers for Medicare & Medicaid Services Office of Minority Health (CMS OMH) released a new Z code infographic entitled: Improving the Collection of Social Determinants of Health (SDOH) Data with ICD-10-CM Z Codes (2023). This resource aims to assist providers with understanding and using Z codes to improve the quality and collection of health equity data.

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FDA Approvals

On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.

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Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Reblozyl^® (luspatercept-aamt) for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

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On September 26, 2023, the Food and Drug Administration approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg.

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Are you interested in learning about and staying up to date with VENCLEXTA?

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FDA Approvals

On July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

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Pfizer Oncology is proud to announce the FDA approval of ELREXFIO™ (elranatamab-bcmm).

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Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced on August 2, 2023 that the FDA has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

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Coding and Reimbursement Updates

View the August E-Reimbursement Newsletter

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For the first time, the law provides Medicare the ability to directly negotiate the prices of certain high expenditure, single source drugs without generic or biosimilar competition. These 10 drugs are covered under Medicare Part D and selected for negotiation for initial price applicability year 2026, based on total gross covered prescription drug costs under Medicare Part D and other criteria as required by the IRA (Inflation Reduction Act).

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State and National Legislative & Regulatory Issues

The American Society of Clinical Oncology (ASCO) recently released a position statement on white bagging. The statement was developed in close consultation with leading ASCO volunteers and affirms ASCO’s opposition to the mandated use of white bagging.

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