Shots:

• The US FDA has approved Merck’s Keytruda for the treatment of patients with locally advanced or mUC who are not eligible for any Pt-containing CT & converted the indication from an accelerated to a full approval along with a label update
• Previously- the FDA’s ODAC voted 5-3 in favor of maintaining the accelerated approval of pembrolizumab for mUC after it failed to meet post-marketing requirements
• The therapy has also received FDA approval for patients with locally advanced or mUC who were not eligible for cisplatin-containing CT. The company will continue to advance the therapy in multiple studies as monothx. and in combination with other anti-cancer therapies

  Ref: BUSINESS WIRE | Image: Merck