Can Keytruda plus Padcev replace cisplatin chemotherapy before bladder cancer surgery?
FDA approval moves Keytruda and Padcev into perioperative MIBC regardless of cisplatin eligibility, intensifying the contest for standard care.
Pharma & Biotech
Pharma & Biotech
Pfizer and Astellas secure wider FDA label for Padcev plus Keytruda in muscle-invasive bladder cancer
FDA expands Padcev plus Keytruda to adults with muscle-invasive bladder cancer regardless of cisplatin eligibility, reshaping perioperative care.
Pharma & Biotech
Lupin’s tentative FDA approval for enzalutamide sets up a high-value generic challenge to Xtandi
Lupin Limited has moved closer to the United States enzalutamide market with proposed 120 mg and 160 mg tablets that could reduce pill burden. Patent timing, final approval, market access and competition will determine whether that formulation advantage becomes commercially meaningful.
Pharma & Biotech
PADCEV plus Keytruda meets survival endpoints in cisplatin-eligible bladder cancer patients
Astellas Pharma Inc. and Pfizer Inc. have announced that their antibody-drug conjugate PADCEV (enfortumab vedotin), in combination with the PD-1 inhibitor pembrolizumab (marketed as Keytruda by Merck), met key survival endpoints in the Phase 3 EV-304 trial. In cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC), the combination significantly improved both event-free survival and overall survival