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Amgen seeks full approval of Blincyto for Philadelphia chromosome–negative ALL
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Amgen submitted a supplemental biologics license application to the FDA that seeks to convert an accelerated approval of blinatumomab to full approval.
The accelerated approval — granted in 2014 — allows for use of blinatumomab (Blincyto, Amgen) to treat Philadelphia chromosome–negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The supplemental application included OS data from the phase 3 randomized, active-controlled, open-label TOWER study, which compared the efficacy of blinatumomab with standard-of-care chemotherapy in 405 adults with relapsed or refractory B-cell precursor ALL.
Those data support converting blinatumomab’s accelerated approval to full approval, according to an Amgen press release.
Data included in the supplemental application also support the use of blinatumomab for the treatment of Philadelphia chromosome–positive relapsed or refractory B-cell precursor ALL, Amgen officials said.
“ALL is one of the most aggressive B-cell malignancies, and adult patients who relapse or are refractory to treatment often go through multiple lines of therapy,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a press release. “We are excited to potentially receive full approval for blinatumomab, the first immunotherapy to demonstrate an overall survival benefit versus standard-of-care chemotherapy in patients with relapsed or refractory Philadelphia chromosome–negative B-cell precursor ALL, and bring a much needed new treatment option to those who are Philadelphia chromosome positive.”
Blinatumomab is the first FDA–approved bispecific CD19–directed CD3 T-cell engager antibody. It also is the first single-agent immunotherapy to treat Philadelphia chromosome–negative relapsed or refractory B-cell precursor ALL.