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:
- 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.
- 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.
- 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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