Pfizer’s Avelumab Poised For Speedy Review By FDA
Executive Summary
Avelumab could be the fourth PD-1/L1 inhibitor to reach the market now that the US FDA has accepted Pfizer’s and Merck KGaA’s BLA for priority review in the treatment of metastatic Merkel cell carcinoma.
You may also be interested in...
Keeping Track: Xermelo, Odactra, Noctiva Approved; Second Submissions For Avelumab And Deutetrabenazine
The latest drug development news and highlights from our US FDA Performance Tracker.
Keeping Track: Immuno-Oncologics And Abuse-Deterrent Opioids Take Center Stage (Again); Jardiance CV Claim Approved
The latest drug development news and highlights from our FDA Performance Tracker.
AstraZeneca Clinical Hold Could Be No Real Concern, Or Very Bad For AZ And BMS
The partial clinical hold placed on a combination trial of AstraZeneca’s PD-L1 inhibitor durvalumab and CTLA-4 inhibitor tremelimumab could be a portent of problems for Bristol-Myers Squibb’s PD-1/CTLA-4 combination trials – or it could be related to the head and neck cancer setting.