Industry News
FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
January 11, 2025
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December 20, 2024
- BRAFTOVI in combination with cetuximab and mFOLFOX6 is the first and only combination regimen with targeted therapy approved for use as early as first-line for patients with metastatic colorectal cancer with a BRAF V600E mutation
- Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the Phase 3 BREAKWATER trial
FDA Approves Bristol Myers Squibb’s Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) Injection, for Subcutaneous Use in Most Previously Approved Adult, Solid Tumor Opdivo® (nivolumab) Indications
January 11, 2025
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December 27, 2024
Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor
Given over three- to five-minutes, Opdivo Qvantig demonstrated consistent efficacy and showed a comparable safety profile to intravenous Opdivo in the Phase 3 CheckMate-67T trial
FDA Approves BeiGene’s TEVIMBRA® (tislelizumab-jsgr) First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with Chemotherapy
January 11, 2025
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Dec 27, 2024 6:00 AM
New indication based on results from a global Phase 3 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival for patients with advanced gastric cancers
Second FDA approval for TEVIMBRA in 2024