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Amgen Submits FDA Application for Blinatumomab for Acute Lymphoblastic Leukemia

Biologic has breakthrough therapy and orphan drug status

Amgen has submitted a biologics license application (BLA) to the FDA seeking approval for blinatumomab in the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Blinatumomab is the first investigational bispecific T-cell engager (BiTE) antibody construct, an immunotherapy approach that helps the body's immune system target cancer cells. Blinatumomab is designed to direct the body's cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas.

Blinatumomab has received both orphan drug designation and breakthrough therapy designation from the FDA for the treatment of ALL. The FDA states that breakthrough therapy designation, which is intended to expedite review of drugs for serious or life-threatening conditions, requires preliminary clinical evidence that demonstrates the drug may have substantial improvement over available therapies on at least one clinically significant endpoint.

The submission includes data from a phase II trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab.

That study was described this year at the American Society of Clinical Oncology meeting. Blinatumomab was given by continuous intravenous infusion (four weeks on, two weeks off) for up to five cycles. The primary endpoint was complete remission (CR) or CR with partial hematological recovery (CRh) within the first two cycles. As of January 2014, 43% of patients achieved CR or CRh; 80% of responses occurred within cycle 1.

In the U.S., it is estimated that more than 6,000 cases of ALL will be diagnosed in 2014. In adult patients with relapsed or refractory ALL, median overall survival is just three to five months.

Sources: Amgen; September 22, 2014; and ASCO; May 2014

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