Oncology News & Updates

Updates from ASCO

ASCO has urged CMS to delay the October 1, 2026, launch of the GLOBE drug pricing model until the administration can better evaluate its potential impact on oncology practices. While supporting lower patient costs, the association remains concerned that the new benchmark could unintentionally restrict access to critical cancer care.

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Molecular Inference–Based Deep Learning Assesses CNS Tumor Diagnosis: The accuracy of a hierarchical molecular inference–based deep-learning system, Neuropath-AI, was tested in central nervous system tumor diagnosis and classifications in a retrospective study. ASCO to Update Guideline for Multiple Myeloma.

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Corporate Member News

Bristol Myers Squibb Announces Positive Phase 3 Results from the SUCCESSOR-2 Study of Oral Mezigdomide in Relapsed or Refractory Multiple Myeloma.

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Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line.

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Institutional News

• A Phase II Study of Amivantamab SC (Subcutaneous) in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)  This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug directed against the MET gene. The primary objective is to evaluate the objective response rate (ORR).  

Click her to see the study protocol

For more information or to refer a patient, please contact UC Davis Comprehensive Cancer Center, Office of Clinical Research via email at OCRReferral@health.ucdavis.edu or by phone at 916-382-6970.

Updates from ASCO

The American Society of Clinical Oncology and Conexiant have launched ASCO AI in Oncology, a new digital platform dedicated to helping oncology professionals navigate the rapidly evolving world of artificial intelligence. This trusted resource provides curated, expert-led insights, practical education on enhancing diagnostic accuracy and workflows, and a space for global clinicians to share real-world implementation experiences.  READ MORE

“Massive Shift” Prompts ASCO to Update Guideline for Multiple Myeloma.

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New data published in the American Cancer Society’s (ACS) Cancer Statistics, 2026 report show that, for the first time, the 5-year survival rate for all cancers combined has reached 70% for individuals diagnosed during 2015 to 2021 in the United States. In addition, those diagnosed with high-mortality cancers and advanced diagnoses experienced the largest gains in survival.

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Corporate Member News

FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

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FDA approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

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New Publication Alert: Learn More About Real-World Outcomes in ER+/HER2- ESR1-Mutant Metastatic Breast Cancer

Clinical Cancer Research has recently featured two complimentary publications detailing the outcomes of patients administered an oral SERD with ESR1-mutant metastatic breast cancer

Lloyd et al., 2025

Rugo et al., 2025 

Coding and Reimbursement Updates

This Month’s E-Reiumbursement Newsletter from Bobbi Buell for January 2026.

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FDA Approvals

FDA approved new, flexible dosing regimens for TEVIMBRA® (tislelizumab-jsgr) from BeOne Medicines USA.

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Updates from ASCO

ASCO Chief Medical Officer Julie Gralow warns that unstable federal funding is causing a "cancer brain drain" that threatens America’s scientific leadership and the future of life-saving breakthroughs.

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Rates of multiple myeloma, the second most common blood cancer in the United States, are increasing and are twice as high in men than in women. A new study published in the journal Cancer provides insights that may help to explain this disparity.

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The Centers for Medicare & Medicaid Services released two proposed drug pricing models—Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD)—intended to reduce Medicare spending by aligning U.S. drug prices with international pricing benchmarks. Both models target high-cost, single-source drugs, which includes many chemotherapy and immunotherapy agents.

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FDA Approvals

The Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024).

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Coding and Reimbursement Updates

This Month’s E-Reiumbursement Newsletter from Bobbi Buell for October 29, 2025. In this edition:  TrumpRx, New CPT Codes, Modifier 25 and More…

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Oncologists are getting hit with yet another one-two payment punch under a new national downcoding policy from Cigna.

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E-Reimbursement SPECIAL EDITION–Medicare Physician Fee Schedule Final Rule 2026

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Details are not yet available (and have not been officially posted), but the Continuing Resolution (“CR”) signed by President Trump yesterday will continue telehealth as it was, allowing patients to receive care at home. That’s the good news. The bad news is that it will only be restored until January 30th through this bill. If you have been holding telehealth claims, stay tuned.

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State and National Legislative & Regulatory Issues

On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule (PFS) final rule for 2026. The rule finalizes physician reimbursement and policy reforms under the PFS as well as changes to reporting requirements and policy updates for the Quality Payment Program.

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Last week, after agreeing to a deal to end the federal government shutdown, Congress passed a continuing resolution that would reopen the government, at least through January 30, 2026.  Within the continuing resolution package was an extension of the Medicare telehealth waivers, which had previously expired on October 1, 2025 (NOTE: The package contained several divisions, however the link provided in this newsletter only goes to the section containing the telehealth items).  In the passed legislation, the telehealth waivers that had expired will now be extended through January 30, 2026.

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FDA Approvals

KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) Subcutaneous Injection 165 mg/ 2,000 units per mL is indicated for use in adult patients across most solid tumor indications for KEYTRUDA® (pembrolizumab) Injection 100 mg—whether alone or in combination with other therapies.

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The Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).

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The U.S. Food and Drug Administration (FDA) has issued multiple safety updates affecting oncology drugs, including new labeling requirements for postapproval safety issues, Risk Evaluation and Mitigation Strategy (REMS) program changes, boxed warnings for CAR-T and chemotherapy agents, and mandatory genetic testing requirements to prevent fatal toxicities.

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The Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

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The Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.

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The Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.

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The Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.

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The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.

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FDA Approvals

The Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.

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The Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

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The Food and Drug Administration (FDA) has required this safety notice as part of the COPIKTRA REMS (Risk Evaluation
and Mitigation Strategy) to inform about updates to the Prescribing Information in July 2024.

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US FDA adds label warning to J&J’s and Legend Biotech’s cancer therapy.

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The Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.

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State and National Legislative & Regulatory Issues

The Board of Pharmacy’s compounding regulations are now effective. The approved regulations clearly exempt physicians, which is something CMA advocated for throughout the process. This rulemaking package was of interest to multiple specialties.

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CMS has instructed all Medicare Administrative Contractors (MACs) to continue temporarily holding claims with dates of service on or after October 1, 2025, for services impacted by the expired Medicare legislative payment provisions under the Full-Year Continuing Appropriations and Extensions Act, 2025.

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Effective Oct. 1, oncology practices will have a wide range of new International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM) coding options, thanks to the 2026 code set that will take effect then.

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National Guideline Updates

NCCN Guidelines Navigator for Breast Cancer Genetic Testing and Treatment Debuts During Breast Cancer Awareness Month.

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ASCO News and Updates

In a study reported in JCO Oncology Practice, Kirkwood et al identified recent changes in and characteristics of the hematologist/medical oncologist (oncologist) workforce in the United States, with the data revealing gaps in coverage according to age and other patient demographics.

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ASCO Members: How is the Government Shutdown Impacting You?
The Association for Clinical Oncology (ASCO) is urgently collecting stories on how the government shutdown is impacting our members’ ability to provide patient care and conduct research.

Please share examples concerning delays to critical services or the interruption of cancer trials and research activities.

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ASCO Edge – Essential Practice Management Education for Oncology Professionals
The American Society of Clinical Oncology (ASCO) ASCO Edge initiative, an online oncology practice and operations management educational series developed by oncology professionals for oncology professionals. ASCO Edge content is a member-only benefit that provides members with education and the tools to effectively manage the business side of  their practices. Through modules covering topics from employment law to leadership and succession planning, members will gain the foundational understanding and advanced insights needed to effectively manage practice operations and continue to deliver exceptional patient care. Please share this with your membership and encourage them to get started today.

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ACT Now! Tell Congress to Make Telehealth Flexibilities Permanent
Medicare telehealth flexibilities expired on September 30. It’s crucial that Congress hears from you today about the importance of continued access to telehealth services for patients with cancer.

Due to Congress’s lack of action, pre-pandemic telehealth restrictions are back in place, meaning that patients have to be in a designated rural area and go to an approved site, rather than their own homes, to receive telehealth care.

For patients with cancer, telehealth provides essential access to care for those who need it most, and we must tell Congress to make the previous telehealth flexibilities permanent by supporting the CONNECT for Health Act (H.R. 4206/ S. 1261). Please ask your members to urge your lawmakers to restore our patients’ access to telehealth!

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Corporate Member Highlights

From Be One Medicines: BRUKINSA tablets will be available in late October 2025.

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The American Cancer Society and Pfizer have launched a three-year initiative, “Change the Odds,” aimed at improving health outcomes in medically underrepresentedcommunities across the United States by increasing awareness of and access to: Cancer Screenings, Patient Support & Navigation and Clinical Trials

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FDA Approvals

The Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck).

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The Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

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Coding and Reimbursement Updates

E-Reimbursement Newsletter: Volume 35, Issue 8, September 2025 –  Ready for the Shutdown–Telehealth, OPPS Q4, Prior Auth/WISeR

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Effective Oct. 1, oncology practices will have a wide range of new International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM) coding options, thanks to the 2026 code set that will take effect then.

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FDA Approvals

Jazz Pharmaceuticals Announces U.S. FDA Approval of ModeysoTM (dordaviprone, Jazz Pharmaceuticals)  as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma.

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Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.

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DATROWAY® (datopotamab deruxtecan-dlnk, Daiichi Sankyo) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFRmutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinumbased chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial

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Coding and Reimbursement Updates

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Northern California Clinical Trials

UCSF Helen Diller Family Comprehensive Cancer Center

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ELEGANT Clinical Trial Overview

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FDA Approvals

LYNOZYFIC is now approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

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Pfizer Oncology is pleased to share that on July 11, 2025, the FDA approved a less frequent dosing option for certain responding patients being treated with ELREXFIO® (elranatamab-bcmm).  ELREXFIO is approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

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Astellas Pharma US, Inc. is pleased to announce the U.S. Food and Drug Administration (FDA) approval of a 300 mg vial size (NDC: 0469-4425-30) for VYLOY Ò
(zolbetuximab-clzb) in addition to its current 100 mg vial size (NDC: 0469-3425-10).

For more information, please visit VyloyHCP.com.

Please click here for the full Prescribing Information.

For important state pricing disclosure information, click here.

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U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels

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Coding and Reimbursement Updates

Bobbi Buell’s E-Reimbursement newsletter for July is now available online. It includes an update on The Proposed Medicare Part B Rules 2026, OPPS Proposal for 2026

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FDA Approvals

On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

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On June 13, 2024, the Food and Drug Administration granted accelerated approval to repotrectinib (AUGTYRO, Bristol-Myers Squibb Company).

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On June 14, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

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On June 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.

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On June 21, 2024, the Food and Drug Administration granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc., a Bristol Myers Squibb company) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).

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On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

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FDA LINK

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National Guideline Updates

The National Comprehensive Cancer Network (NCCN) is seeking community oncology practices to participate in the Health Equity Report Card Pilot Project in Community Oncology settings.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates^®) for Endometrial Carcinoma and Uterine Sarcoma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Uterine Neoplasms v2.2024.

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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 v6.2024.

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

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates^®) for Classic Follicular Lymphoma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for B-Cell Lymphomas v2.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Thyroid Carcinoma. 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 Drugs & Biologics Compendium (NCCN Compendium^®) for Small Cell Lung 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^®) for Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Gene Fusions. 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 Radiation Therapy Compendium^™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC^™) for Acute Lymphoblastic Leukemia. 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^®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) for Non-Small Cell Lung Cancer. These NCCN Guidelines^® are currently available as Version 7.2024.

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The NCCN Drugs & Biologics Compendium (NCCN Compendium^®) for Non-Small Cell Lung Cancer v6.2024 has been updated and published based on the most recent changes from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®).

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Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here:

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Other

Noridian Medicare Jurisdiction E Part B

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California Medical Association Practices Resources (CPR):

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