Categorized | Regulatory

Bristol immunotherapy gets six month U.S. FDA review for melanoma

Source: Reuters, September 2014

Reuters) – The U.S. Food and Drug Administration has granted a six-month, priority review to Bristol-Myers Squibb Co’s application for immuno-oncology drug Opdivo as a treatment for previously treated melanoma, the company said on Friday.

The FDA decision is due by March 30, 2015.

Bristol said European regulators have also agreed to an accelerated review of the drug as a treatment for advanced melanoma.

Opdivo, or nivolumab, is part of a promising new class of drugs designed to help the body’s own immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to evade disease-fighting cells.

Merck & Co Inc’s Keytruda, or pembrolizumab, became the first PD-1 drug available in the United States, when the FDA earlier this month approved its use for patients with advanced melanoma who are no longer responding to other therapies.

Companies including Roche Holding AG and AstraZeneca Plc are also developing PD-1 pathway drugs for a variety of cancers, including lung cancer. Some analysts expect the new class could generate more than $30 billion in annual sales worldwide by 2025.

Bristol said Opdivo was also designated by the FDA as a “breakthrough” melanoma therapy. The agency earlier this year designated the drug as a breakthrough therapy for patients with Hodgkin lymphoma who had failed other treatments.

In April, Bristol initiated a “rolling” submission with the FDA for Opdivo use in certain patients with a type of non-small cell lung cancer. The company said it expects to complete that application by the end of the year.

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