Sunday, March 1, 2015

FDA Grants Priority Review To BMS's Opdivo® -- In Previously-Treated Lung Cancers

And with this Friday afternoon news, just as I predicted, BMS has seized the lead in a "significant burden" oncology line (NSCLC), over Merck's Keytruda®.

For its part, Merck expects to file in the first half of 2015 -- but that likely puts Merck more than six months behind BMS's Opdivo®. Just as I said over a year ago, now.

From the BMS press release, then:

. . . .BMS today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics Licensing Application (BLA) for Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The FDA also granted Priority Review for this application. The Prescription Drug User Fee Act (PDUFA) goal date for a decision is June 22, 2015. . . .

So. . . now Merck will be playing "catch up" in NSCLC. Ouch.

1 comment:

Anonymous said...

It might not be as bad as it appears. The BMY filing is for 3L squamous cell NSCLC. MRK will file for 2L NSCLC, squamous and non-squamous, in patients with tumor cells expressing PD-L1, the PD-1 receptor ligand. BMY gets there first, but MRK potentially gets to the market soon after with a substantially larger opportunity.