Amgen has received approval from US Food and Drug Administration (FDA) for its Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Approved through accelerated approval, Blincyto is the first FDA-approved bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct product and the first single-agent immunotherapy to treat Ph- relapsed or refractory B-cell precursor ALL.
Ph- relapsed or refractory B-cell precursor ALL is a rare and rapidly progressing cancer of the blood and bone marrow said Amgen.
Amgen research and development executive vice-president Sean Harper said: "The FDA’s breakthrough therapy designation and accelerated approval of Blincyto underscores the critical need for new treatment options for patients with relapsed or refractory B-cell precursor ALL, who are often young adults.
"Blincyto is the first clinical and regulatory validation of the BiTE platform, a new and innovative approach that helps the body’s own immune system fight cancer."
The approval was based on results of ‘211 trial, a Phase II, multicentre and single-arm open-label study.
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According to the company, 41% of 185 patients evaluated in the trial achieved complete remission or complete remission with partial haematologic recovery (CR/CRh) within two cycles of treatment with Blincyto.
In addition, FDA approved a risk evaluation and mitigation strategy (REMS) for Blincyto, while it was approved to inform healthcare providers of the serious risks of CRS, neurological toxicities, preparation and administration errors.
Amgen, along with its subsidiary Onyx Pharmaceuticals, will market Blincyto in the US. Blincyto was also granted breakthrough therapy and priority review designations by the FDA.
Image: One of the many buildings at Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.