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FDA Designation for Bristol-Myers/AbbVie Candidate - Analyst Blog

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Bristol-Myers Squibb ( BMY ) and partner AbbVie ( ABBV ) announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to their oncology candidate, elotuzumab.

Bristol-Myers and AbbVie are developing elotuzumab for the treatment of patients suffering from multiple myeloma (MM). The breakthrough therapy designation has been granted to the candidate in combination with Celgene 's ( CELG ) Revlimid and low-dose dexamethasone for treating MM patients who have received one or more prior therapies for MM (relapsed or refractory MM).

The FDA granted the designation on the basis of data from a phase II study that evaluated the cocktail therapy across 2 doses (10 mg/kg and 20 mg/kg) in previously-treated patients. The combination is currently being evaluated in two phase III studies (ELOQUENT-1 and ELOQUENT-2) at the 10 mg/kg dose. While the ELOQUENT-1 study is evaluating the combination as a first-line therapy for MM, ELOQUENT-2 is assessing the same in the relapsed or refractory MM setting.

Bristol-Myers and AbbVie are also studying elotuzumab in a phase II study in combination with Velcade in patients suffering from relapsed or refractory MM.

The designation, which was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act, is granted to potential new treatments for serious or life-threatening diseases. The designation should help fasten the development and review process for the candidate. The MM market, with a significant unmet medical need, offers significant commercial potential.

Earlier in the month, the FDA assigned a similar designation to another promising oncology candidate, nivolumab, at Bristol-Myers. The designation was granted for the hodgkin lymphoma indication.

Both Bristol-Myers and AbbVie carry a Zacks Rank #3 (Hold). Allergan ( AGN ) is a better-ranked stock in the healthcare space with 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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