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FDA Designation for Merck Candidate

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Merck & Co. Inc. (MRK - Free Report) recently announced that the US Food and Drug Administration (FDA) granted breakthrough therapy designation to its oncology candidate, lambrolizumab (MK-3475).

Merck is developing lambrolizumab for the treatment of patients with advanced melanoma and other tumor types. The breakthrough therapy designation is for the advanced melanoma indication.

As per American Cancer Society, 9,180 people in the US died in the year 2012 due to advanced melanoma.

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 or conditions where the initial clinical data shows that the treatment has the potential to demonstrate substantial improvement on one or more clinically significant endpoints compared to existing treatments. The designation should help fasten the development and review process for the candidate

In Nov 2012, phase Ib results of lambrolizumab were announced and a phase II study was initiated.

Apart from Merck, companies like Pfizer Inc. (PFE - Free Report) , Pharmacyclics, Inc. and Novartis AG (NVS - Free Report) have also recently received breakthrough therapy designation for their candidates.

Pfizer was granted breakthrough therapy designation for its oncology candidate, palbociclib (PD-0332991). Pharmacyclics was granted breakthrough therapy designation for ibrutinib for treating chronic lymphocytic leukemia / small lymphocytic lymphoma patients with a deletion of the short arm of chromosome 17p.

Earlier in the year, the US regulatory body had granted breakthrough therapy designation to ibrutinib for treating mantle cell lymphoma patients as a monotherapy. Novartis was granted breakthrough therapy designation for its pipeline candidate LDK378, which is being developed for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC).

Merck carries a Zacks Rank #3 (Hold). Pharmacyclics is well-positioned with a Zacks Rank #2 (Buy).

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