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
Ref: Merck & Co. | Image: Merck
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