The U.S. FDA has accepted Amgen’s supplemental Biologics License Application (sBLA) for BLINCYTO (blinatumomab) to include overall survival data from the Phase 3 TOWER study, Amgen said in a press release.
Also included in the application is new data supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), Amgen said. The goal of the application is to “expand BLINCYTO's indication for the treatment of all patients with relapsed or refractory B-cell precursor ALL and supports the conversion of BLINCYTO's accelerated approval to full approval,” Amgen said.
BLINCYTO is “the first-and-only FDA-approved CD19-directed CD3 bispecific T cell engager antibody,” Amgen said, and it had earlier been given breakthrough therapy designation and accelerated approval. In addition, BLINCYTO is the first single-agent immunotherapy approved to treat those suffering from Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL, Amgen said.
"Patients with relapsed or refractory ALL generally have a very poor prognosis,” Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said in the release.
“The median overall survival – or OS – on standard of care chemotherapy is just four months,” Harper said. “BLINCYTO is the first-and-only approved bispecific immunotherapy with superior OS results versus 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.”