FDA announced Wednesday that it has approved Amgen’s Blincyto (blinatumomab) for a rare form of acute lymphoblastic leukemia. The immunotherapy medicine engages the body’s white blood cells or lymphocytes to destroy leukemia cells. The drug is intended for patients in whom the cancer has returned after treatment. Blincyto was granted a Priority Review, Breakthrough Therapy designation and deemed an orphan product by FDA. Thirty-two percent of patients in a clinical trial taking Blincyto showed a complete remission of the disease for approximately 6.7 months. Amgen purchased Blincyto in 2012 for $1.2 billion from Micromet.
FDA approves Amgen leukemia immunotherapy
Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.
