NEW YORK – Amgen on Wednesday said the US Food and Drug Administration granted full approval to Blincyto (blinatumomab) as a treatment for patients with minimal residual disease (MRD)-positive, CD19-positive B-cell precursor acute lymphoblastic leukemia who are in their first or second remission.
According to Amgen, the FDA relied on data from two Phase III studies to convert the drug's 2018 accelerated approval into full approval for adult and pediatric patients who have MRD of at least 0.1 percent despite achieving remission on at least two prior therapies.
Blincyto, a bispecific T-cell engager that targets CD19 surface antigens on B cells, is also approved in the US for adults and children with refractory CD19-positive B-cell precursor ALL.
"In a Phase II study, roughly 80 percent of adult patients treated with blinatumomab experienced a complete MRD response," Elias Jabbour, a professor in the division of cancer medicine at MD Anderson Cancer Center, said in a statement. "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."
Amgen is also planning to seek approval for Blincyto in newly diagnosed MRD-negative ALL patients based on results from the ECOG-ACRIN E1910 trial reported in December.