Amgen’s Cancer Treatment Receives FDA Breakthrough Therapy Designation

The FDA has granted breakthrough therapy designation to Amgen’s bispecific T cell engager (BiTE) antibody blinatumomab for the treatment of a rapidly progressing blood and bone marrow cancer, paving the way for speedy development and review of the drug.

The designation was based on results of a Phase 2 trial of 189 adult patients with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.

The results provide a strong basis for a regulatory filing later this year, said Sean Harper, executive vice president of research and development at Amgen.

According to the company, there is a high unmet need for new medicines to treat relapsed and refractory ALL patients. FDA criteria for the breakthrough therapy designation require preliminary clinical evidence that the candidate may result in substantial improvement on at least one clinically significant endpoint versus available therapy.

Drugmakers that garner the designation receive intensive FDA guidance on an efficient drug development program and are eligible for rolling and priority reviews. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.