FDA fast tracks Amgen’s Blincyto leukemia drug
Thousand Oaks-based biotech giant Amgen announced March 29 that the U.S. Food and Drug Administration has fast-tracked the company’s leukemia drug Blincyto for priority review.
The drug increases the length of survival among high-risk patients, according to a study released by the New England Journal of Medicine. It almost doubled median overall survival versus chemotherapy among adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, one of the most aggressive forms of cancer.
“Patients with relapsed or refractory all generally have a very poor prognosis,” said Dr. Sean E. Harper, executive vice president of research and development at Amgen.
The median overall survival – or OS – on standard of care chemotherapy is just four months.
“Blincyto is the first-and-only approved bispecific immunotherapy with superior OS results versus standard of care chemotherapy, nearly doubling the median OS for patients with this form of all. We look forward to making this important potential new option available to patients with all forms of relapsed or refractory B-cell,” Harper said.
Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. The Prescription Drug User Fee Act target action date is Aug. 14.
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