FDA grants full approval to Amgen’s Blincyto

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FDA grants full approval to Amgen’s Blincyto

By David Salazar - 07/12/2017

SILVER SPRING, Md. — Patients with a certain type of acute lymphoblastic leukemia have a new treatment option. The Food and Drug Administration has granted Amgen’s Blincyto (blinatumomab) full approval for the treatment of Philadelphia Chromosome-positive relaped or refractory B-cell precursor ALL.

“We are pleased that the FDA has granted full approval for Blincyto, marking a significant milestone for certain patients with relapsed or refractory ALL,” Amgen EVP research and development Dr. Sean Harper said. “This approval supports the use of Blincyto in a broader spectrum of patients, including those with few options to date, such as Philadelphia chromosome-positive patients, and reinforces the potential of the [bispeciic T cell engager] platform as a novel approach to immuno-oncology.”

The drug had previously been granted breakthrough therapy designation and accelerated approval.

“Relapsed or refractory ALL is often a lethal disease, with a median overall survival of just four months on standard-of-care chemotherapy,” Moffitt Cancer Center oncologist Dr. Bijal Shah said. “As a physician, my goal is to identify treatments that improve response rates in patients with aggressive hematologic malignancies. Blincyto is an option that has been shown to help these high-risk patients fight their disease."