Amgen recently announced that it has submitted a supplemental Biologics License Application (sBLA) for the company’s Blincyto drug to the U.S. Food and Drug Administration (FDA).
If approved, the company will be allowed to include recent data that suggests the treatment can be used for both adolescent and pediatric patients who have Philadelphia chromosome-negative (Ph-) relapse. It may also be approved to treat the same patients if they have refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Both Ph- relapsed and refractory B-cell precursor ALL -- which is the most common cancer found in children -- are rapidly progressing and rare cancers. They affect the bone marrow and blood of children as well as adults.
"Children with relapsed or refractory ALL have very poor long-term outcomes, and currently there are limited available therapies to induce remission," Sean Harper, executive vice president of research and development at Amgen, said. "We look forward to collaborating with regulatory authorities to make Blincyto available to this ultra-orphan patient population with a high unmet medical need."
Blincyto is the first and only available treatment that the FDA has approved for bispecific CD19-directed CD3 T-cell engager (BiTE) immunotherapy. It is available in the U.S. with a specific accelerated approval permission.