FDA approves Keytruda for kidney cancer

Federal regulators approved Keytruda, a drug used to treat melanoma and head and neck cancer, as an adjuvant treatment for stage II and stage III renal cell carcinoma, according to Merck.

Locations of the cancer will be monitored prior to treatment and chronic long-term monitoring will be recommended, said Merck, Inc.

One in 100 Americans will be diagnosed with kidney cancer in any given year. This represents a significant unmet need for patients and physicians, Merck said.

Merck, the U.S. subsidiary of the Europe-based pharmaceutical company, said the approval, approved Friday by the Food and Drug Administration under Priority Review, is not available for late-stage renal cell carcinoma (RCC).

Moreover, the FDA’s Chemo-NCCRC approval application for Keytruda is still under review, Merck said.

This combination of the company’s latest lung cancer drug and chemotherapy is the first to combine these two cancer-fighting agents, said the pharmaceutical giant.

It is the first targeted immunotherapy to be shown to lengthen survival in phase III clinical trials in stage II and stage III renal cell carcinoma, Merck said.

“We are excited to be able to offer another innovative treatment for kidney cancer,” said Thomas C. Lynch, chairman and chief executive officer of Merck.

He said Keytruda combined with a prior first-line chemotherapy will help both patients and their physicians address the unmet need for a previously untreated or unresectable, but potentially treatable, kidney cancer.

“Over 50,000 people are living with kidney cancer in the United States, with an average life expectancy of just three to five years, and more than half of these patients experience relapses and end-stage disease,” Lynch said.

“Thanks to the work of our researchers and clinicians, we are developing new treatments that can extend the lives of patients living with this disease,” he added.

Merck said the approval is the latest milestone in developing new cancer therapies.

It said the treatment has been shown to improve overall survival by at least 10 months in late-stage lung cancer patients.

More than 1,100 cancer researchers and clinicians have been involved in the development of Keytruda.

They have identified over 100 different molecules that are generated by targeted immune cells called neoantigens and expressed by many tumor types.

Merck said meta-immunotherapy is the combination of targeted drugs to stimulate the immune system to better fight cancer.

Research indicates that as many as 80 percent of immunotherapy-responding patients reported signs of disease reduction or complete tumor regression — compared to just over half of patients treated with chemotherapy and targeted drugs alone, the company said.

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