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news.Amgen has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for Blincyto (blinatumomab) to treat a rare form of acute lymphoblastic leukemia (ALL).
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The sBLA includes new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL.
The filing was based on phase 2 study showing Blincyto offers meaningful therapeutic benefits in difficult-to-treat type of pediatric ALL.
Blincyto is currently available under an accelerated approval in the US to treat Ph- relapsed or refractory B-cell precursor ALL.
Amgen executive vice president of research and development Sean Harper said: "Children with relapsed or refractory ALL have very poor long-term outcomes and currently there are limited available therapies to induce remission.
"We look forward to collaborating with regulatory authorities to make Blincyto available to this ultra-orphan patient population with a high unmet medical need."
Amgen said Blincyto is a bispecific CD19-directed CD3 T cell engager antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.
The FDA granted breakthrough therapy and priority review designations to Blincyto. It also has conditional marketing authorization in the European Union to treat adults with Ph- relapsed or refractory B-precursor ALL.