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US Regulators Approve New Cancer Drug with Novel Action

  • Jessica Berman

FILE - In this Feb. 28, 2013 file photo, a Merck logo is placed on scientist's lab coat in West Point, Pa.

FILE - In this Feb. 28, 2013 file photo, a Merck logo is placed on scientist's lab coat in West Point, Pa.

The U.S. Food and Drug Administration this week gave the green light to the pharmaceutical company Merck’s anti-cancer compound Keytruda, a novel drug designed to fight advanced melanoma.

Keytruda has a unique action, enlisting the body’s immune response against the lethal cancer. Normally, cancerous tumors disarm the immune system. But Keytruda inhibits the action of one of the proteins tumors use to block immune response.

Known generically as pembrolizumab, the drug reportedly is safe with few side effects. Conventional chemotherapy drugs target fast-growing cancer cells and can cause disabling side effects.

Cancer experts have been anxiously awaiting speedy regulatory approval of a new drug to fight the deadliest form of skin cancer.

The FDA gave speedy approval to Keytruda after a large, phase one safety trial.

In a study involving 173 patients, distant tumors from the original cancer shrank in about a quarter of cases. The positive effect lasted up to eight-and-a-half months.

But Keytruda is very expensive. Merck has set the price of the drug at more than $12,000 per month. A year’s worth of treatment with Keytruda adds up to around $150,000.

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