publication date: Mar. 30, 2018

Drugs and Targets

FDA gives accelerated approval for Blincyto for ALL patients with minimal residual disease

FDA granted an accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease.

MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse.

The agent is sponsored by Amgen Inc.

“This is the first FDA-approved treatment for patients with MRD-positive ALL,” said Richard Pazdur, director of the FDA Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Because patients who have MRD are more likely to relapse, having a treatment option that eliminates even very low amounts of residual leukemia cells may help keep the cancer in remission longer. We look forward to furthering our understanding about the reduction in MRD after treatment with Blincyto. Studies are being conducted to assess how Blincyto affects long-term survival outcomes in patients with MRD.”

The FDA Oncologic Drugs Advisory Committee March 7 voted to accept the metric of “minimal residual disease,” or MRD, as a basis for approval of a drug for the treatment of acute lymphoblastic leukemia (The Cancer Letter, March 9).

In an 8:4 vote, the committee recommended broadening the indication for the Amgen drug Blincyto (blinatumomab) to include the treatment of MRD-positive B-cell precursor ALL.

ALL is a small indication. There are about 2,500 … Continue reading FDA gives accelerated approval for Blincyto for ALL patients with minimal residual disease

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