Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Late last week, Amgen (AMGN) provided an update on its cancer candidate, blinatumomab. The company said that the Biologics License Application (BLA) for blinatumomab has been accepted and granted priority review designation by the FDA. 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 FDA is expected to render a final decision on the candidate by May 19, 2015.
We note that the company is also looking to get blinatumomab approved in the EU for the above-mentioned indication and has submitted a marketing application for the same.
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The regulatory filings include 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.
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) Iclusig.
Blinatumomab is also being evaluated as a potential treatment for non-Hodgkin’s lymphoma (NHL) and other hematologic malignancies including pediatric relapsed/refractory ALL.
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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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