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FDA grants priority review to Blincyto for expanded ALL indication
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The FDA granted priority review to blinatumomab to expand its indication to include all patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, according to the drug’s manufacturer.
The application also supports the conversion of the agent’s accelerated approval to full approval based on OS data from the phase 3 TOWER study.
Blinatumomab (Blincyto, Amgen) — the only FDA–approved CD19–directed CD3 bispecific T-cell engager, or BiTE, antibody — is the first single-agent immunotherapy approved to treat patients with Philadelphia chromosome–negative (Ph–) relapsed or refractory B-cell precursor ALL.
The randomized, open-label TOWER study evaluated the efficacy of blinatumomab compared with standard-of-care chemotherapy in 405 adults with Ph– relapsed or refractory B-cell precursor ALL.
Median OS was longer in patients treated with blinatumomab (7.7 months; 95% CI, 5.6-9.6) than patients treated with standard of care (4 months; 95% CI, 2.9-5.3; HR = 0.71). Treatment with blinatumomab almost doubled OS compared with standard-of-care chemotherapy when used in first salvage treatment (11.1 months vs. 5.3 months).
The study was closed early based on efficacy per the recommendation of an independent data monitoring committee.
Safety data were consistent with those found in previous studies. Cough, pyrexia and cytokine release syndrome occurred at an incidence rate that was at least 5% higher for patients treated with blinatumomab than standard of care.
The supplemental biologics license application also includes new data from the ALCANTARA study on patients with Philadelphia chromosome–positive relapsed or refractory B-cell precursor ALL.
Results — published in Journal of Clinical Oncology — showed 16 of 45 patients (36%; 95% CI, 22-51) with Ph+ B-cell precursor ALL achieved complete remission or complete remission with partial hematologic recovery to blinatumomab during the first two cycles. Median RFS was 6.7 months and median OS was 7.1 months.
“Patients with relapsed or refractory ALL generally have a very poor prognosis. The median overall survival on standard of care chemotherapy is just 4 months,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a company-issued release. “Blincyto is the first-and-only approved bispecific immunotherapy with superior OS results vs. standard-of-care chemotherapy, nearly doubling the median OS for patients with this form of ALL. We look forward to making this important potential new option available to patients with all forms of relapsed or refractory B-cell ALL.”
The Prescription Drug User Fee Act target action date is set for Aug. 14.