BMS to Apply for FDA Approval of Nivolumab in Q3

Posted By
7/10/2014 8:45pm
View other posts by
Replies: 0

BMS announced today that they'll be making their official application to the FDA for approval of their PD-1 checkpoint inhibitor nivolumab this fall.  Of lesser importance, they're going with the brand name Opdivo.  MarketWatch article here:

Bristol-Myers Squibb Announces Plans for Third Quarter Submission of a Biologics License Application for Opdivo®(nivolumab), an Investigational PD-1 Immune Checkpoint Inhibitor, for Previously Treated Advanced Melanoma

Interesting because many expected that BMS would wait until early 2015 to submit.  They'll be seeking approval similar to the way Merck's approval will likely come through and the EAP's are being constructed, namely that it will require prior failure with ipilimumab (Yervoy), and for BRAF-positive patients, prior BRAF-targeted therapy.  First-line approval would then come later once the final Phase III trials are completed.