) shares were up 1.64% after the company announced that the FDA
has granted Breakthrough Therapy Designation to its experimental
oncology drug, blinatumomab for the treatment of adults suffering
from Philadelphia-negative (Ph-) relapsed/refractory B-precursor
acute lymphoblastic leukemia (ALL).
Breakthrough Therapy designation is a status provided to
potential candidates that show superiority over existing
therapies for the treatment of serious or life threatening
diseases or conditions. The designation helps fasten the
development and review process for experimental drugs targeting
serious and life-threatening diseases. A candidate with
Breakthrough Therapy designation could benefit from the FDA's
existing fast track development program features as well as more
intensive FDA guidance on efficient development of the
Blinatumomab is investigational bispecific T cell engager
(BiTE) antibody. The candidate received the Breakthrough Therapy
Designation on the basis of the encouraging results from aphase
II trial on adults with Ph- relapsed/refractory B-precursor
As per the company sources, ALL accounts for more than 12% of
leukemia but carries a very bleak prognosis. Almost 74% of the
patients diagnosed die from the disease. Currently available
therapies for ALL include
ARIAD Pharmaceuticals, Inc.
Blinatumomab is also being developed for the treatment of
non-Hodgkin's lymphoma (NHL) and has the potential to be
developed for other hematologic malignancies including pediatric
While, blinatumomab enjoys orphan drug designation for the
treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell
leukemia, prolymphocytic leukemia and indolent B cell lymphoma in
the U.S., it has received the same in the EU for the treatment of
indolent B cell lymphoma, ALL, CLL and mantle cell leukemia.
Amgen presently carries a Zacks Rank #3 (Hold).Some
better-ranked stocks in the biotech sector include
Biogen Idec Inc.
Horizon Pharma, Inc.
). Both are Zacks Rank #1 (Strong Buy) stocks.
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AMGEN INC (AMGN): Free Stock Analysis Report
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