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Bristol-Myers/AbbVie Empliciti Gets Approved in the EU

Bristol-Myers Squibb Company BMY and AbbVie Inc. ABBV announced that Empliciti was approved in the EU, in combination with Celgene Corp.’s CELG Revlimid plus dexamethasone, for the treatment of multiple myeloma in patients who have received at least one prior therapy. This makes Empliciti the first and the only immunostimulatory antibody to be approved in the EU for the treatment of multiple myeloma.

The approval was quite expected as the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a favorable opinion this January.

We note that Empliciti is approved in the U.S., in combination with Revlimid plus dexamethasone, for the treatment of patients with multiple myeloma who have received one to three prior therapies.

Another drug approved in the EU in this indication is Amgen Inc.’s AMGN Kyprolis, in combination with Revlimid and dexamethasone. Currently, Amgen is working on expanding its label. The company has filed a regulatory application seeking an approval for Kyprolis, in combination with dexamethasone, for the same indication.

According to information provided by the company, it is estimated that more than 114,200 new cases of multiple myeloma are diagnosed every year, and over 80,000 people die from the disease worldwide.

In a separate press release, Bristol-Myers announced that the European Commission (EC) has approved Opdivo in combination with Yervoy for the treatment of adults with advanced (unresectable or metastatic) melanoma. The approval was based on data from two studies, CheckMate -067 (phase III) and CheckMate -069 (phase II).

We remind investors that last month, the EC approved Opdivo monotherapy in two indications – locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults; and advanced renal cell carcinoma after prior therapy in adults.

It is estimated that 100,000 new cases of melanoma are diagnosed every year in the EU, with over 20,000 deaths occurring from the disease.

AbbVie currently carries a Zacks Rank #3 (Hold). Bristol-Myers, with a Zacks Rank #1 (Strong Buy), is a better-ranked stock in the health care sector.

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BRISTOL-MYERS (BMY): Free Stock Analysis Report
 
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