Bristol-Myers Squibb Company BMY announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency rendered a positive opinion recommending approval of oncology drug Opdivo for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) following chemotherapy in adults.
The European Commission generally takes the CHMP’s opinion into account while reviewing candidates and hence an approval might be on the cards.
Last month, the CHMP gave a positive opinion on Opdivo for the treatment of advanced melanoma.
We note that in 2014, the FDA cleared Bristol-Myers’ Opdivo, for the treatment of patients suffering from unresectable or metastatic melanoma and disease progression following Yervoy and, in case of BRAF V600 mutation-positive patients, a BRAF inhibitor. Opdivo's label was further expanded by the FDA in Mar 2015 to include the treatment of patients with metastatic squamous NSCLC, who experienced progression on or after platinum-based chemotherapy.
We believe that Opdivo has the potential to boost the company’s revenues significantly. Opdivo is one of the key products in Bristol-Myers’ portfolio and in the first quarter of 2015, following its launch in Dec 2014, the drug generated revenues of $40 million.
A potential approval in additional geographies will further boost the drug’s growth potential.
Meanwhile, in Apr 2015, the FDA accepted the supplemental Biologics License Application (sBLA) for Opdivo for filing and review for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted priority review for this application. A final decision from the FDA is expected by Aug 27, 2015.
Bristol-Myers carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Valeant Pharmaceuticals International, Inc. VRX, Gilead Sciences Inc. GILD and Actelion Ltd. ALIOF. All three carry a Zacks Rank #1 (Strong Buy).
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