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
Click here to read full press release/ article | Ref: BUSINESS WIRE | Image: Merck
The post Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Label Update to Treat Advanced Urothelial Carcinoma first appeared on PharmaShots.
