Major Biotech Stock in News: Amgen Files Blinatumomab Marketing Application

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Amgen (AMGN) announced that it has submitted a Biologics License Application (BLA) to the FDA for its oncology candidate, blinatumomab. The company is looking to get the candidate approved for the treatment of adults suffering from Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

The BLA includes positive data from a phase II study which evaluated the use of blinatumomab in adults with Ph- relapsed/refractory B-precursor ALL. Blinatumomab is an investigational bispecific T cell engager (BiTE) antibody. We remind investors that blinatumomab has Breakthrough Therapy designation for the ALL indication, which should accelerate the review process for the candidate.

According to the American Cancer Society, approximately 6,020 new cases of ALL are likely to be diagnosed in 2014 in the U.S. The disease has a very bleak prognosis with median overall survival in adult patients with relapsed or refractory ALL being only three to five months, according to company sources. Currently available therapies for ALL include ARIAD Pharmaceuticals, Inc.’s (ARIA) Inclusive.

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Blinatumomab is also being evaluated as a potential treatment for non-Hodgkin’s lymphoma (NHL) and other hematologic malignancies including pediatric relapsed/refractory ALL.

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.

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Amgen, which has filed for regulatory approval of quite a few candidates (talimogene laherparepvec – cancer, ivabradine – chronic heart failure, evolocumab – high cholesterol) over the last few months, is now seeking approval for another experimental cancer treatment – blinatumomab.

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