FDA grants Amgen's Blincyto accelerated approval for acute lymphoblastic leukaemia

The FDA approved Amgen's immunotherapy Blincyto (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) precursor B-cell acute lymphoblastic leukaemia (B-cell ALL), the agency announced Wednesday. The US regulator remarked that Blincyto is "the first approved drug that engages the body’s T-cells...to destroy leukaemia cells."

The clearance of the bispecific T-cell engager, which was granted both breakthrough therapy status and priority review, was supported by data from a Phase II study of 185 patients with Ph- B-cell ALL. In the study, 32 percent of patients who received the drug achieved complete remission for a median duration of about 6.7 months.

Amgen acquired Blincyto in its 2012 purchase of Micromet for about $1.2 billion. The drug is being co-developed with Astellas under a long-term strategic alliance to develop new treatments for the Japanese market.

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