Good news flowed in at Bristol-Myers Squibb Company (BMY) from the U.S. and EU with the regulatory authorities accepting the marketing applications for the company’s high potential immuno-oncology candidate Opdivo (nivolumab, a PD-1 immune checkpoint inhibitor) for review.
The FDA announced that it will review the Biologics License Application (BLA) for Opdivo on a priority basis. A response from the U.S. regulatory body should be out by Mar 30, 2015. Bristol-Myers is seeking approval of the candidate for use in treatment experienced advanced melanoma patients.
Bristol-Myers sought FDA approval for the indication on the basis of positive results from a phase III study (Checkmate -037). The patients in the trial were previously treated with Yervoy and with a BRAF inhibitor regimen in case they were BRAF-mutation positive.
We note that the U.S. regulatory authority generally reviews those drugs which offer major advances in treating diseases over existing therapies on a priority basis.
Opdivo is also under review in the EU for the same indication. The marketing application has been granted accelerated assessment status by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
We remind investors that Merck & Co. Inc. (MRK) gained FDA approval for its anti-PD-1 therapy Keytruda earlier this month. Controversy erupted immediately thereafter with Bristol-Myers filing a patent infringement lawsuit against Merck (read more: Bristol-Myers Sues Merck of Patent Infringement on Keytruda).
The immuno-oncology market is highly lucrative. Other than Bristol-Myers, companies such as Roche (RHHBY) are also developing immuno-oncology treatments.
Bristol-Myers carries a Zacks Rank #2 (Buy). A better-ranked stock in the health care space is Gilead Sciences (GILD), sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment