Amgen Lands Breakthrough Designation for Leukemia Drug

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The US Food and Drug Administration has granted breakthrough designation to Amgen for a drug designed to treat acute lymphoblastic leukemia (ALL).

Amgen scored the 'coveted status' of breakthrough drug for its mid-stage leukemia treatment blinatumomab, based on phase II data of patients with Philadelphia-negative relapsed or hard to treat B-precursor ALL.

Blinatumomab falls into the preferred wheelhouse of FDA cancer chief Richard Pazdur, who has a habit of fast-tracking cancer meds in areas where the meds meet an unmet need.

Blinatumomab is a bispecific T cell engager (BiTE) that uses an antibody to redirect killer T cells to destroy tumor cells. In that respect it is among the new generation of treatments in clinical trial against cancer that attempt to enlist the body's own immune system in fighting the disease.

"There is a high unmet need for new medicines to treat relapsed and refractory ALL patients, who have very few treatment options," said Amgen R&D chief Sean Harper in a statement. "The results from the Phase II trial evaluating blinatumomab in adult patients with relapsed or refractory ALL are encouraging and provide a strong basis for a regulatory filing later this year and potential approval in this serious disease."

Source: Fiercebiotech

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