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Amgen's Blincyto Gets FDA Nod, Carries Boxed Warning

Amgen Inc.’s (AMGN) Blincyto (blinatumomab) gained FDA approval for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This makes Blincyto the first bispecific CD19-directed CD3 T-cell engager (BiTE) antibody and the first single-agent immunotherapy to be approved by the FDA for this indication. Approval came more than five months ahead of schedule.

We remind investors that the FDA was expected to render a final decision on the candidate by May 19, 2015.

The accelerated approval was based on positive data from a phase II study which evaluated the use of Blincyto in adults with Ph- relapsed/refractory B-cell precursor ALL. Blincyto significantly improved the rates of complete remission in ALL patients.

However, Blincyto’s approval in the U.S. comes with a boxed warning regarding cytokine release syndrome (CRS) and neurological toxicities. Moreover, the drug will be available under a Risk Evaluation and Mitigation Strategy.

We note that Blincyto 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 Blincyto 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.

We are pleased with the FDA approval of Blincyto. Amgen currently has other important pipeline candidates like evolocumab (dyslipidemia) under FDA review.

Amgen currently carries a Zacks Rank #1 (Strong Buy). Some equally well-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP), Biogen Idec Inc. (BIIB) and Illumina Inc. (ILMN).

Read the Full Research Report on AMGN
Read the Full Research Report on ILMN
Read the Full Research Report on BIIB
Read the Full Research Report on ANIP


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