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Bristol-Myers’ Opdivo Gets EU Approval for Label Expansion

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Bristol-Myers Squibb Company BMY announced that the European Commission has approved its immuno-oncology drug, Opdivo, for an additional indication. Opdivo has been approved for the treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with Adcetris (brentuximab vedotin).

This makes Opdivo the first and only PD-1 inhibitor to be approved for a hematologic malignancy in the EU. The approval was based on the overall response rate established by data from an integrated analysis of two studies – CheckMate -205 (phase II) and CheckMate -039 (phase I).

The EU approval was not surprising as the European Medicines Agency’s Committee for Medicinal Products for Human Use had issued a favorable opinion this October.

BRISTOL-MYERS Price


We are encouraged by the latest label expansion of Opdivo. Per Bristol-Myers’ press release, cHL is the most common type of Hodgkin lymphoma and accounts for 95% of all cases. Hence, the drug will now cater to the previously unmet needs of patients who relapse or become refractory to the currently available treatments.

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

Moreover, Opdivo is approved in both the U.S. and the EU for several cancer indications. Bristol-Myers is working on further expanding its label. Opdivo is currently under priority review in the U.S. for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in patients who have progressed on or after platinum-containing therapy. A response from the FDA is expected by Mar 2, 2017. The product is also under review in the EU for the mUC indication.

We note that Opdivo gained FDA approval a couple of weeks back for intravenous use to treat patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy. The drug is also under review in the EU for the same indication.

Opdivo has recorded worldwide sales of $2.5 billion in the first nine months of 2016. 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 Sucampo Pharmaceuticals, Inc. SCMP, Vanda Pharmaceuticals, Inc. VNDA and Anika Therapeutics Inc. ANIK. While Sucampo and Vanda sport a Zacks Rank #1 (Strong Buy), Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Vanda’s loss per share estimates narrowed from 68 cents to 56 cents for 2016, while earnings per share estimates increased from 16 cents to 17 cents for 2017, over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged 80% year to date.

Sucampo’s earnings per share estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017, over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.

Anika’s earnings per share estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017, over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 21% year to date.

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