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FDA Grants Full Approval to ALL Therapy


July 12, 2017

The US Food and Drug Administration (FDA) has granted full approval to a treatment for B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.
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Blincyto (blinatumomab, Amgen Inc) has been elevated from accelerated approval to full approval based on data from the phase II ALCANTARA and the phase III TOWER studies. Blincyto is the first single-agent immunotherapy approved to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL. The drug is also the first and only FDA approved CD19-directed CD3 bispecific T-cell engager immunotherapy.

"Relapsed or refractory ALL is often a lethal disease, with a median overall survival (OS) of just four months on standard of care chemotherapy," said Bijal D Shah, MD, medical oncologist, Moffitt Cancer Center (Tampa, FL), in a press release (July 11, 2017). "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."

The TOWER study, which provided the basis for full approval, found that Blincyto demonstrated significant increase in median OS compared with standard of care chemotherapy (7.7 months vs 4 months, respectively; HR, 0.71; P = 0.012) for adult or pediatric patients with relapsed or refractory B-cell precursor ALL.

Safety results among patients who received Blincyto were comparable to those seen in the ALCANTARA study, including elevated risk of pyrexia, infusion-related reactions, cough, cytokine release syndrome, tremor, and decreased immunoglobulins, researchers noted.

"We are pleased that the FDA has granted full approval for Blincyto, marking a significant milestone for certain patients with relapsed or refractory ALL," said Sean E Harper, MD, executive vice president, Research and Development, Amgen, in an interview (June 11, 2017).—Zachary Bessette

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