Bristol-Myers Gets CHMP Backing for Opdivo's Expanded Use
Bristol-Myers Squibb Company BMY announced that the Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion in favor of the approval of Opdivo in combination with Yervoy for the treatment of adults suffering from advanced (unresectable or metastatic) melanoma. The CHMP however added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival for the combination of Opdivo with Yervoy is established only in patients with low tumor PD-L1 expression.
The CHMP opinion was based on data from two studies, CheckMate -067 (phase III) and CheckMate -069 (phase II), in addition to supportive data from a phase Ib study – CA209-004.
We note that Opdivo as a monotherapy is already approved in the EU for the treatment of advanced melanoma and previously treated advanced squamous non-small cell lung cancer (NSCLC).
The drug recorded worldwide revenues of $942 million in 2015. Meanwhile, the company continues to work on label expansion of the drug. This February, the company received positive CHMP opinions in favor of the approval of Opdivo for two additional indications – for the treatment of previously treated advanced or metastatic non-squamous NSCLC and renal cell carcinoma.
The favorable opinions of the CHMP will be reviewed by the European Commission. With the CHMP issuing positive opinions, we believe the chances of Opdivo gaining EU approval for expanded use are high.
Meanwhile, the company is also looking to get Opdivo approved in the EU for the treatment of patients with classical Hodgkin lymphoma after prior therapies. Label expansion should boost the drug’s commercial potential significantly.
Bristol-Myers is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Actelion Ltd. ALIOF, Anika Therapeutics Inc. ANIK and AMAG Pharmaceuticals, Inc. AMAG. All three stocks carry a Zacks Rank #1 (Strong Buy).
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