Industry News
11/21/2025[Duplicate] FDA Approves BeiGene’s TEVIMBRA® (tislelizumab-jsgr) First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with ChemotherapyNew 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 Read More |
11/21/2025FDA approves (Zepzelca) lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancerOn October 2, 2025, 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. Full prescribing information for Zepzelca, Tecentriq, and Tecentriq Hybreza will be posted on Drugs@FDA. Read More |
11/21/2025FDA approves (LIBTAYO) cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinomaOn October 8, 2025, 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. Second FDA approval for TEVIMBRA in 2024 Read More |
12/27/2024FDA Approves BeiGene’s TEVIMBRA® (tislelizumab-jsgr) First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with ChemotherapyNew 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 Read More |
12/27/2024FDA Approves Bristol Myers Squibb’s Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) Injection, for Subcutaneous Use in Most Previously Approved Adult, Solid Tumor Opdivo® (nivolumab) IndicationsOpdivo 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 Read More |
12/20/2024FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal CancerBRAFTOVI 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 Read More |
