FDA approves Keytruda as an adjuvant treatment for advanced kidney cancer

WASHINGTON — The U.S. Food and Drug Administration on Wednesday approved Keytruda as an adjuvant treatment for people with previously untreated, advanced kidney cancer.

Keytruda is now approved to treat a total of nine solid tumor cancers — ovarian, lung, bladder, esophageal, melanoma, non-small cell lung cancer, gastric and kidney.

The decision followed a unanimous vote among an independent panel of experts who concluded it was safe and effective to continue, or expand, the use of Keytruda in patients with advanced kidney cancer. The FDA usually follows the advice of its advisory panels.

The drug is made by Merck & Co. But Kite Pharma, a biotech company in Santa Monica, California, filed a lawsuit against Merck earlier this month alleging that the Merck didn’t consult or “respond” to a patent application or designs that could prevent rivals from using the same technology to create drugs that target Keytruda.

The patent dispute will be decided by a federal court in the Southern District of California.

Merck is currently involved in separate patent battles with Bristol-Myers Squibb, Roche and other pharmaceutical companies over its use of PD-1 inhibitors in fighting solid tumors.

Kite sued the Merck in 2016, arguing that the drug infringed on two patents. The patents focused on the idea that using an immune system to attack cancer helps maximize its effectiveness.

Keytruda is the most-sold drug in the Merck’s line of cancer treatments, including cancer vaccines Gardasil and Keytruda. Keytruda sales reached $2.9 billion in 2017, up 35 percent from the previous year.

This story was originally published on STAT.

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