Replies to post #228031 on Biotech Values

[DewDiligence]

The upcoming Keytruda PDUFA date is for second-line bladder cancer (NMIBC): #msg-152848797. (MRK hasn't disclosed the exact date, as far as I know.)

[DewDiligence]

FDA approves Keytruda monotherapy for second-line NMIBC, regardless of PD-L1 status:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer

This accelerated approval is based on the single-arm KEYNOTE-057 study. ODAC backed approval by a 9-4 vote (#msg-152848797).

[DewDiligence]

EPZM—FDA approves Tazverik (tazemetostat) for epithelioid sarcoma (metastatic or locally advanced):

https://www.businesswire.com/news/home/20200123005858/en/Epizyme-Announces-U.S.-FDA-Accelerated-Approval-TAZVERIK%E2%84%A2

This is an accelerated approval based on ORR (15%; 95% CI: [0.07-0.26]) and duration of response (67%>=6m) in a single-arm trial of 58 patients. (There was one complete response.)

FDA approvals of a new agent for any kind of sarcoma are pretty rare. The stock is flat in AH trading, so apparently this approval was considered a fait accompli.