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FDA grants full approval to Blincyto for acute lymphoblastic leukemia
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The FDA approved a supplemental biologics license application for blinatumomab, according to the agent’s manufacturer.
The agency previously granted accelerated approval to blinatumomab (Blincyto, Amgen) for treatment of children and adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The FDA’s decision converts that to full approval.
Blinatumomab is the only FDA–approved CD19–directed CD3 bispecific T-cell engager immunotherapy.
The supplemental application included data from the phase 3 TOWER study, which showed blinatumomab nearly doubled median OS compared with chemotherapy (7.7 months vs. 4 months (HR = 0.71; P = .012).
“For researchers and physicians, overall survival is the primary goal of treatment and the gold standard of outcomes, demonstrating a clear value to patients,” study researcher Anthony Stein, MD, codirector of Gehr Family Center for Leukemia Research at City of Hope, said in an Amgen-issued press release. “Data from the TOWER study support the use of this single-agent bispecific T cell engager (BiTE) immunotherapy, the first to demonstrate superior overall survival in patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL, offering a much needed alternative with significantly improved outcomes over standard of care chemotherapy.”
The FDA also considered data from the phase 2 ALCANTARA study, which evaluated the efficacy of blinatumomab among adults with Philadelphia chromosome–positive relapsed 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,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the press release. “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 BiTE platform as a novel approach to immuno-oncology.”
The prescribing information for blinatumomab includes a boxed warning for cytokine release syndrome and neurologic toxicities. The agent also is under a risk evaluation and mitigation strategy program in the United States.