Amgen Submits sBLA for Full Blincyto Approval

The sBLA aims to include overall survival data from the Tower Phase 3 study.
The sBLA aims to include overall survival data from the Tower Phase 3 study.

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. 

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"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.