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Bristol-Myers Wins CHMP Nod for Opdivo Label Expansion


Bristol-Myers Squibb Company BMY announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo for adults with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with Adcetris (brentuximab vedotin).

The CHMP opinion was based on the overall response rate demonstrated by two studies – CheckMate -205 (phase II) and CheckMate -039 (phase I).

Although the CHMP’s opinion is still subject to a review by the European Commission, we believe that it has increased the odds of Opdivo gaining EU approval for expanded use.

An approval would make Opdivo the first PD-1 inhibitor to treat a hematologic malignancy in the EU.

Per Bristol-Myers’ press release, cHL is the most common type of Hodgkin lymphoma, accounting for 95% of all cases. This represents significant unmet need for patients who relapse or who become refractory to the currently available treatments.


We note that Opdivo gained accelerated approval in the U.S. in May 2016 for cHL in patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation Adcetris treatment.

Moreover, the drug is approved in both the U.S. and the EU for several cancer indications. Bristol-Myers is working on expanding its label even further. Opdivo is currently under priority review in the U.S. for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck. A response from the FDA is expected by Nov 11, 2016. The product is also under review in the EU for the same indication.

We note that Opdivo recorded worldwide sales of $1.5 billion in the first half of 2016. A label expansion in additional indications would give the product access to a higher patient population and increase the commercial potential of the drug significantly.

Zacks Rank & Key Picks

Bristol-Myers currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Incyte Corporation INCY, BioMarin Pharmaceutical Inc. BMRN and Geron Corporation GERN. All the three stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Incyte’s earnings estimates for 2016 and 2017 were up a respective 22.2% and 6.6% over the last 60 days. The company has beaten earnings estimates thrice in the last four quarters with an average surprise of 335.16%.

BioMarin’s loss estimates narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.

Geron has posted a positive earnings surprise in each of the four trailing quarters, bringing the average beat to 20.78%.

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