FDA Expands Indications for BlincytoMarch 30, 2018
The Food and Drug Administration (FDA) has granted accelerated approval to Blincyto (blinatumomab; Amgen, Inc.), expanding indications for use to include the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in first or second complete remission but still have minimal residual disease (MRD) ≥ 0.1%.
Blincyto is now the first FDA-approved treatment for patients with MRD-positive ALL. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
FDA approval for the new indication follows an 8 to 4 vote earlier this month from the agency’s Oncologic Drugs Advisory Committee (ODAC) to recommend approval. The ODAC based its recommendation on results of the single-arm phase II BLAST study, which was recently published online in the Journal Blood (Gökbuget et al., 2018).
Blincyto was first approved by the FDA in 2014 for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL. The Blincyto label carries a boxed warning regarding risk of cytokine release syndrome (CRS) and neurological toxicities.
Food and Drug Administration (FDA). FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse [news release]. March 29, 2018. Available at: click here. Accessed March 29, 2018.