4 September 2014 - The FDA on Thursday approved the first of an eagerly awaited new class of cancer drugs that unleashes the body’s immune system to fight tumours.

The drug, which Merck will sell under the name Keytruda, was approved for patients with advanced melanoma who have exhausted other therapies.

But the treatments will not be inexpensive. Merck said Thursday that the drug, known generically as pembrolizumab, would cost about $12,500 a month, or about $150,000 a year.

Keytruda was approved based on what was essentially an extra-large Phase 1 trial involving 173 participants who all received the drug, with no control group. Tumours shrank in about 245 of patients, the F.D.A. said, with the effect lasting at least 1.4 to 8.5 months and continuing beyond this period in most patients.

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