Amgen Submits sBLA for Full Blincyto Approval
Amgen has announced the submission of a supplemental Biologics License Application (BLA) for Blincyto (blinatumomab) to the Food and Drug Administration (FDA), to include overall survival data from the TOWER Phase 3 study. The sBLA also includes new data supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Blincyto is a bispecific CD19-directed CD3 T cell engager antibody that gained accelerated approval from the FDA for the treatment of Philadelphia chromosome-negative (Ph–) relapsed or refractory B-cell precursor ALL. The Phase 3 TOWER study is a confirmatory trial, which investigated the efficacy of Blincyto vs. standard of care (SOC) chemotherapy in 405 patients with Ph– relapsed or refractory B-cell precursor ALL.
"We are excited to potentially receive full approval for Blincyto, the first immunotherapy to demonstrate an overall survival benefit versus standard of care chemotherapy in patients with relapsed or refractory Ph- B-cell precursor ALL, and bring a much needed new treatment option to those who are Ph+,” said Sean Harper, MD, EVP of Research and Development at Amgen.
For more information visit Amgen.com.