Merck’s Keytruda sBLA Receives FDA Priority Review for Treatment of Locally Advance or mMCC
Merck’s Keytruda sBLA Receives FDA Priority Review for Treatment of Locally Advance or mMCC
Shots:
- The sBLA is based on P-II KEYNOTE-017 study including ORR and DOR for 1L merkel cell carcinoma(MCC), study shows most DTC in MCC patients
- The US has set a PDUFA date of Dec 28, 2018, additionally Keytruda also received a BT Designation by FDA in July 2017
- Keytruda (pembrolizumab) 100mg IV is being evaluated in >800 ongoing trials across different tumours in various geographies
Click here to read full press release/ article | Ref: Merck & Co. | Image: Merck