FDA Approves Bristol-Myers Immunotherapy for Lung Cancer
Monday, March 9, 2015
U.S. health regulators on Wednesday swiftly approved a Bristol-Myers Squibb Co drug that helps the immune system fight the most common form of lung cancer, sending the company's shares up more than 5 percent to a multi-year high.
The eagerly anticipated Food and Drug Administration approval of the drug known as Opdivo came only about three months after Bristol provided trial results showing that the medicine extended survival in non-small cell lung cancer (NSCLC), one of the biggest markets in oncology. The decision also came more than three months ahead of an expected action date by the agency.
"This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials," Richard Pazdur, the FDA's head of hematology and oncology product evaluation, said in a statement.