Tags: Cancer | opdivo | lung | cancer | FDA

Lung Cancer Immune Drug OKd by FDA

Wednesday, 04 March 2015 04:52 PM

U.S. health regulators on Wednesday swiftly approved a Bristol-Myers Squibb drug that helps the immune system fight the most common form of lung cancer, sending the company's shares up more than 5 percent.

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.

Opdivo, known chemically as nivolumab, was approved to treat non-small cell lung cancer after the disease has progressed following platinum-based chemotherapy, typically the first-line treatment against the disease. It was previously approved to treat advanced melanoma, the deadliest form of skin cancer.

Opdivo belongs to a highly promising new class of medicines called PD-1 inhibitors that work by blocking a mechanism tumors use to hide from the immune system, allowing it to recognize and attack cancer cells.

Opdivo was reviewed under the FDA's priority review program, which provides for an expedited review of drugs the agency believes would provide significant improvement in treating a serious condition.

Analysts believe lung cancer could add billions of dollars in annual sales for Opdivo.

Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new cases and 159,260 deaths in 2014. Non-small cell lung cancer is by far the most common type of the disease.

© 2020 Thomson/Reuters. All rights reserved.


   
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U.S.health regulators on Wednesday swiftly approved a Bristol-Myers Squibb drug that helps the immune system fight the most common form of lung cancer, sending the company's shares up more than 5 percent.The eagerly anticipated Food and Drug Administration approval of the...
opdivo, lung, cancer, FDA
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2015-52-04
Wednesday, 04 March 2015 04:52 PM
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