Replies to post #989 on Bristol Myers Squibb (BMY)

[DewDiligence]

PDUFA for Opdivo in adjuvant MUIC is 9/3/21 (with priority review):

https://www.businesswire.com/news/home/20210430005094/en

The sBLA is based on the CHECKMATE-274 study.

[DewDiligence]

FDA approves Opdivo monotherapy in adjuvant MIUC:

https://www.businesswire.com/news/home/20210820005285/en

Bristol Myers Squibb today announced that Opdivo (nivolumab) 240 mg every two weeks or 480 mg every four weeks…was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

The approval is based on the CHECKMATE-274 study (#msg-161630427).