Posted by Michael Wonder on 21 Jun 2023
FDA grants full approval for Blincyto (blinatumomab) to treat minimal residual disease positive B-cell precursor acute lymphoblastic leukaemia
21 June 2023 - Conversion from accelerated to full approval.
Amgen today announced that the US FDA has approved the supplemental biologics license application for Blincyto (blinatumomab) for the treatment of adults and paediatric patients with CD19 positive B-cell precursor acute lymphoblastic leukaemia in first or second complete remission with minimal residual disease greater than or equal to 0.1%, based on additional data from two Phase 3 studies that were submitted.
