FDA Approves MRK's Keytruda & Keytruda SC Combo in Bladder Cancer

Key Takeaways MRK gains FDA approval for IV and SC Keytruda with Padcev for cisplatin-ineligible MIBC.KEYNOTE-905 showed a 60% cut in EFS risk and 50% OS improvement versus surgery alone.Approval follows study data supporting perioperative use of Keytruda plus Padcev regimen in MIBC.Merck (MRK) announced that the FDA has approved both the intravenous (“IV”) and the subcutaneous (under the skin or SC) formulation of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), each in combination with Pfizer’s ...