Blincyto is now approved for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) of at least 0.1%.
The drug was initially granted an accelerated approval in March 2018, based on data from the single-arm BLAST trial, which showed that the 18-month relapse-free survival (RFS) rate was 56% in efficacy-evaluable patients. In addition, 81.4% of patients achieved undetectable minimal residual disease (MRD).
Blincyto is a BiTE (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells.
BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells.
By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.
Amgen said it is continuing to advance a ‘robust development plan’ for Blincyto, including studies aimed at treating patients with MRD-negative B-ALL, trials designed to minimize chemotherapy, and the clinical investigation of a subcutaneous formulation, all intended to help address remaining unmet needs for patients.
David Reese, executive vice president of research and development at Amgen, said: "We are pleased the FDA has granted full approval for Blincyto, the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy and the first to be FDA-approved for MRD in 2018.”
"Today's full approval underscores the clinical benefit of Blincyto for people living with B-ALL, and we look forward to exploring how we can continue to make a significant impact for these patients."
Elias Jabbour, professor of medicine in the department of leukemia, University of Texas, added: "In a Phase 2 study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD response.”
"The FDA's decision to grant a full approval for blinatumomab further validates the use of this therapy to treat adults and children with B-cell precursor ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population."