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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