Amgen has announced the full approval by the US Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab).

Blincyto is used to treat adults and children with CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL), who are in their first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

Approved after additional data was submitted from two phase 3 studies, Blincyto’s accelerated approval is now a full approval.

David Reese, executive vice president of research and development at Amgen commented that the treatment was “the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy, and the first to be FDA-approved for MRD in 2018". He added that the “full approval underscores the clinical benefit of Blincyto for people living with B-ALL”.

Blincyto is a bispecific T-cell engager (BiTE) immune-oncology therapy that targets CD19 surface antigens on B cells. Helping the body’s immune system fight cancer by detecting and targeting malignant cells, BiTE molecules bring T cells nearer to cancer cells, thereby enabling T cells to inject toxins and cause cancer cell death.

"In a phase 2 study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD response," said Elias Jabbour, principal investigator from the department of Leukaemia at the University of Texas MD Anderson Center in Houston.

Blincyto was granted breakthrough therapy and priority review designations by the FDA in the US and is indicated for use as a monotherapy in the EU.

The potential of BiTE immune-oncology therapies like Blincyto to treat a wide variety of cancers is currently being investigated and Amgen will continues to advance its development programme for Blincyto. This includes studies to treat patients with MRD-negative B-ALL, trials designed to minimise the use of chemotherapy and the clinical investigation of a subcutaneous formulation.

Reference：
https://www.pmlive.com/pharma_news/amgens_supplemental_biologics_license_application_for_blincyto_approved_by_fda_1493791