Bristol-Myers Files for New Indications for Yervoy, Opdivo - Analyst Blog

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Bristol-Myers Squibb CompanyBMY announced that the FDA has accepted its supplemental biologics license application (BLA) for Yervoy as an adjuvant treatment of patients suffering from stage-III melanoma, who are at high risk of recurrence following complete surgical resection. An action from the FDA is expected by Oct 28, 2015.

We note that Yervoy is already approved as monotherapy for unresectable or metastatic melanoma.

According to Bristol-Myers, a majority of the stage-III melanoma patients experience disease recurrence within a span of five years, almost 90% of which is found in patients who had been identified to be at highest risk. Going by historical data, survival rates in patients following recurrence of the disease are as low as 11% - 20%.

Meanwhile, Bristol-Myers is working on expanding Yervoy's label further. The company is evaluating the drug in a development program across types of multiple tumors, including prostate and lung cancers (phase III).

Meanwhile, Bristol-Myers's BLA for Opdivo has been accepted by the FDA for the treatment of patients suffering from advanced squamous non-small cell lung cancer (NSCLC) in patients who have undergone prior therapy. The FDA granted priority review for the application and an action from the agency is expected by Jun 22, 2015.

Bristol-Myers filed for Opdivo's approval in this indication on the basis of a phase II single-arm, open-label study, CheckMate-063. We note that Opdivo is already approved in the U.S. (where it received accelerated approval) and Japan for the treatment of patients with unresectable or metastatic melanoma who suffer from disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. The product is in the registrational process in Europe for advanced melanoma and advanced squamous NSCLC.

Opdivo enjoys fast track designation in the U.S. for the treatment of NSCLC, renal cell carcinoma and metastatic melanoma.

Bristol-Myers carries a Zacks Rank#3 (Hold). Some better-ranked stocks in the health care sector are Cytokinetics, Inc. CYTK , ANI Pharmaceuticals, Inc. ANIP and Horizon Pharmaceuticals HZNP . All these stocks carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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