Pfizer Secures FDA Approvals for Two Cancer Drugs; Oncolytic Virus Pipeline Expands
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
The U.S. Food and Drug Administration has granted full approval for Pfizer's BRAFTOVI and VEPPANU, two cancer treatments targeting specific genetic mutations, while the oncolytic virus cancer therapy pipeline continues to grow with over 120 companies developing more than 125 drugs.
BRAFTOVI, in combination with cetuximab and fluorouracil-based chemotherapy, was approved for BRAF V600E metastatic colorectal cancer based on Phase 3 BREAKWATER data showing progression-free survival and overall survival benefits. VEPPANU (vepdegestrant) received approval for ESR1 mutated ER+/HER2- advanced or metastatic breast cancer. Following the VEPPANU approval, Pfizer entered an exclusive global license deal with Rigel for development and commercialization, with up to $405 million in upfront, transition, and milestone payments plus tiered royalties.
Pfizer also reported positive late-stage oncology data across several programs, including ELREXFIO in relapsed or refractory multiple myeloma, TALZENNA plus XTANDI in HRR mutated metastatic prostate cancer, and PADCEV plus Keytruda in muscle invasive bladder cancer. Multiple Phase 3 readouts are being taken to regulators.
Separately, regulators in China approved Pfizer’s GLP-1 treatment Xianweiying for adult weight management.
The oncolytic virus cancer therapy pipeline remains active, with a report indicating 120+ companies and 125+ pipeline drugs in development. In December 2025, Replimune initiated a Phase 2 study of RP2 oncolytic immunotherapy in combination with atezolizumab plus bevacizumab for hepatocellular carcinoma and biliary tract cancer. In November 2025, Genelux Corporation began a Phase 3 trial of Olvi-Vec followed by chemotherapy and bevacizumab for platinum-resistant/refractory ovarian cancer, and TILT Biotherapeutics announced a Phase 1/1b trial of TILT-123 in combination with Pembrolizumab for platinum-resistant ovarian cancer.
Leading companies in the oncolytic virus space include Genelux Corporation, Candel Therapeutics, CG Oncology, DNAtrix, SillaJen Biotherapeutics, and Oncolytics Biotech, among others. Promising pipeline therapies include Gemcitabine, Valacyclovir, CG0070, Keytruda, atezolizumab, and Ipilimumab.