Merck & Co. Inc.
) 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
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
) 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
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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