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

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

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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