Amgen has announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Blincyto (blinatumomab) to include overall survival (OS) data from the phase 3 TOWER study, supporting the conversion of Blincyto's accelerated approval to full approval.
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). The application aims to broaden Blincyto's indication for the treatment of patients with relapsed or refractory B-cell precursor ALL.
Blincyto was previously granted breakthrough therapy designation and accelerated approval in December 2014. It is also the first FDA-approved bispecific CD19-directed CD3 T cell engager (BiTE) antibody, and the first single-agent immunotherapy to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL.
"Acute lymphoblastic leukemia 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," said Sean E. Harper, MD., executive vice president of research and development at Amgen. "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+."
Results from the TOWER study, investigating the efficacy of Blincyto versus standard of care (SOC) chemotherapy in adult patients with Ph- relapsed or refractory B-cell precursor ALL, were presented during the presidential symposium at the 21st Congress of the European Hematology Association. Blincyto has a boxed warning in its product label regarding Cytokine Release Syndrome (CRS) and neurological toxicities.
ALL is a rare and rapidly progressing cancer of the blood and bone marrow. In adult patients with relapsed or refractory ALL, median OS is just three to five months. Currently, there is no broadly accepted standard treatment regimen for adult patients with relapsed or refractory ALL beyond chemotherapy. In adult ALL, approximately 75 per cent is B-cell precursor ALL, of which 75-80 per cent is Ph- and roughly half will be refractory to treatment or experience relapse.