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Friday, 12/05/2014 11:58:30 AM

Friday, December 05, 2014 11:58:30 AM

Post# of 80490
Amgen gets immunotherapy drug against ALL-neg approved:

"The U.S. Food and Drug Administration today approved [Amgen's] Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL."

"Blincyto is the first approved drug that engages the body’s T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells."

"Blincyto is being approved under the FDA’s accelerated approval program... more than five months ahead of the prescription drug user fee goal date of May 19, 2015, the date the agency was scheduled to complete review of the application."

"Blincyto carries a boxed warning..."

FDA approves Blincyto

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