Expanded Label Sought for Blincyto

Amgen has submitted a supplemental biologics license application to the FDA for blinatumomab (Blincyto).

The application includes new data to support the use of the drug for pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Blincyto is currently the only FDA-approved bispecific CD19-directed CD3 T cell engager immunotherapy available for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.

"Children with relapsed or refractory ALL have very poor long-term outcomes, and currently there are limited available therapies to induce remission," said Sean Harper, executive vice president of Research and Development at Amgen, in a press release. "We look forward to collaborating with regulatory authorities to make Blincyto available to this ultra-orphan patient population with a high unmet medical need."

Although 95% of pediatric patients achieve complete remission with their first line of treatment, around 650 children in the Unites States relapse or become resistant to treatment each year. Patients with relapsed or refractory ALL have an overall survivor rate of less than 10%.

Amgen’s application was based on data from a trial that found Blincyto induced complete remission in a clinically meaningful number of pediatric patients with the disease.