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Amgen Gets Breakthrough Therapy Status for Leukemia Drug

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Amgen’s ( AMGN) 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 candidate.


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 ALL.


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.’s ( ARIA) Iclusig.


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 relapsed/refractory ALL.


While, blinatumomab enjoys orphan drug designation for the treatment of ALL, chronic lymphocytic leukemia ( CLL.TO), 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. ( BIIB) and Horizon Pharma, Inc. ( HZNP). Both are Zacks Rank #1 (Strong Buy) stocks.

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