Pfizer Shows 50% Bladder Cancer Benefit, BRAFTOVI Wins FDA Approval
PADCEV plus Keytruda reduced recurrence or death risk by nearly 50% in cisplatin-eligible muscle-invasive bladder cancer patients. FDA granted full approval to BRAFTOVI with cetuximab and chemotherapy for first-line BRAF V600E-mutant metastatic colorectal cancer after Phase 3 data showed a 51% death risk reduction and 30.3-month median survival.
1. Bladder Cancer Trial Breakthrough
In a pivotal study, Pfizer’s antibody-drug conjugate PADCEV combined with Keytruda cut the risk of recurrence or death by nearly 50% in cisplatin-eligible muscle-invasive bladder cancer patients. This outcome could position the combination as a new post-surgical therapy option and drive future label expansions.
2. BRAFTOVI First-Line Approval
The FDA granted full approval to BRAFTOVI in combination with cetuximab and fluorouracil-based chemotherapy for adults with BRAF V600E-mutant metastatic colorectal cancer, converting accelerated approval to full. Phase 3 BREAKWATER trial data showed a 51% reduction in mortality risk and doubled median overall survival to 30.3 months versus standard chemotherapy, reinforcing the regimen’s potential as a new standard of care.