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Sept 26 (Reuters) - The U.S. Food and Drug Administrationhas granted a six-month, priority review to Bristol-Myers SquibbCo's application for immuno-oncology drug Opdivo as atreatment for previously treated melanoma, the company said onFriday.
The FDA decision is due by March 30, 2015.
Bristol said European regulators have also agreed to anaccelerated review of the drug as a treatment for advancedmelanoma.
Opdivo, or nivolumab, is part of a promising new class ofdrugs designed to help the body's own immune system fend offcancer by blocking a protein known as Programmed Death receptor(PD-1), or a related target known as PD-L1, used by tumors toevade disease-fighting cells.
Merck & Co Inc's Keytruda, or pembrolizumab, becamethe first PD-1 drug available in the United States, when the FDAearlier this month approved its use for patients with advancedmelanoma who are no longer responding to other therapies.
Companies including Roche Holding AG andAstraZeneca Plc are also developing PD-1 pathway drugsfor a variety of cancers, including lung cancer. Some analystsexpect the new class could generate more than $30 billion inannual sales worldwide by 2025.
Bristol said Opdivo was also designated by the FDA as a"breakthrough" melanoma therapy. The agency earlier this yeardesignated the drug as a breakthrough therapy for patients withHodgkin lymphoma who had failed other treatments.
In April, Bristol initiated a "rolling" submission with theFDA for Opdivo use in certain patients with a type of non-smallcell lung cancer. The company said it expects to complete thatapplication by the end of the year. (Reporting By Deena Beasley. Editing by Andre Grenon)
