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Effective after renal cell carcinoma treatment, the drug will be first new drug adjuvant treatment approved for three years
The US Food and Drug Administration has approved Keytruda, an immunotherapy drug made by Merck & Co, as an adjuvant treatment for early-stage kidney cancer.
The drug, widely used for advanced lung and melanoma cancers, can now be added to the suite of drugs used to treat this form of kidney cancer, which is the fifth most common cancer among people in the US.
Merck said the treatment, which is used after treatment with chemotherapy, will be the first new drug adjuvant treatment approved for three years in the US and Europe.
“Adjuvant treatment is a distinct option, often given when the initial treatment has not cured the cancer,” said Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
“However, the treatment must have a meaningful benefit in comparison to standard treatment and must be used with caution in patients with advanced disease or those receiving hematopoietic stem cell transplantation.”
Keytruda has been touted as one of the most effective and convenient therapies for advanced melanoma.
The drug has been shown to work in an overall 12-month survival of 65% among advanced melanoma patients when it is combined with other immunotherapy drugs. It was also shown to help patients who had relapsed or whose cancer had spread to other parts of the body.
Merck stock rose 1.8% to $58.74 in premarket trading in New York.
Novartis is also developing its own adjuvant immunotherapy drug called Kadcyla.