The full approval is based on data showing that 80% of patients with B-ALL experienced a complete MRD response.
The Food and Drug Administration (FDA) granted a full approval to Blincyto (blinatumomab) to treat CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) that is minimal residual disease (MRD)-positive, according to Amgen, the manufacturer of the drug.
MRD is the level of remaining cancer found in blood tests after treatment. To be eligible for treatment with Blincyto, patients must have 0.1% MRD.
"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," said Dr. David M. Reese, executive vice president of Research and Development at Amgen, in a press release. "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."
The approval is based on findings from a phase 2 study that demonstrated that approximately 80% of patients treated with Blincyto experienced a complete MRD response, meaning that disease was no longer detected after therapy.
"The FDA's decision to grant a full approval for (Blincyto) 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,” Dr. Elias Jabbour, of the department of leukemia at The University of Texas MD Anderson Cancer Center in Houston, said in the release.
Side effects to be aware of during treatment with Blincyto include cytokine release syndrome, which is the release of inflammatory molecules called cytokines into the blood, and neurological toxicities. Both can be serious or life-threatening, so it is essential that patients discuss any side effects with their health care team.
Patients on Blincyto also experienced infections, tumor lysis syndrome, neutropenia and febrile neutropenia, effects on their ability to drive/use machines, elevated liver enzymes, pancreatic inflammation or leukoencephalopathy, according to the release.
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