Amgen Stock Rises on Drug ApplicationWednesday, February 15, 2017
The stock of Amgen Inc. rose more than 2 percent Wednesday following an announcement that the Thousand Oaks biotechnology firm has applied for the Food and Drug Administration’s approval to broaden the range of disease conditions that can be treated with its leukemia drug Blincyto.
Blincyto works by stimulating the body’s immune system to destroy cancerous cells found in patients with acute lymphoblastic leukemia.
The FDA granted Blincyto accelerated approval in 2014 for the treatment of a more common form of the disease. Last September the drug was approved in the United States for use in patients with a treatment-resistant “Philadelphia chromosome-negative” subtype. Now, Amgen has applied for approval to label Blincyto as a therapy for treatment-resistant “Philadelphia chromosome-positive” acute lymphoblastic leukemia, a second subtype of the cancer.
The company also requested that the status of the drug be converted from accelerated to full approval for treatment of Philadelphia chromosome-negative acute lymphoblastic leukemia. As evidence of its efficacy, Amgen submitted the results of a study indicating that patients with that form of the disease survived longer than those who did not.
“We are excited to potentially receive full approval for Blincyto, the first immunotherapy to demonstrate an overall survival benefit versus standard of care chemotherapy,” Dr. Sean Harper, executive vice president of research and development at Amgen, said in a prepared statement.
Amgen stock rose $3.74, or about 2.2 percent, on Wednesday to close at $171.79 on the Nasdaq.