Tags: Cancer | FDA | melanoma | treatment | immunology | Keytruda

FDA Approves Broader Melanoma Treatment

FDA Approves Broader Melanoma Treatment
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By    |   Monday, 21 December 2015 01:03 PM

The Food and Drug Administration has approved a new immunology drug for the first line treatment of patients with advanced melanoma.

The immunology drug Keytruda (pembrolizumab), is now approved as a first line treatment for patients in whom melanoma has spread, said researchers at UCLA Los Angeles, where the drug, which is manufactured by Merck, was co-developed.

Previously the drug was only approved for use in advanced melanoma only after other treatments had failed. In taking this step, doctors will be able to prescribe Keytruda first, meaning it will reach far more patients,  the researchers said. 

Keytruda, which has been termed a "breakthrough" drug, was granted accelerated FDA approval last year, but could only be given to patients who were no longer responding to Yervoy (ipilimumab), which is a different type of immunologic drug.

According to the researchers, the FDA approval came following the results of a 16-country study involving 834 patients that were randomly assigned to groups that compared two Keytruda regiments with Yervoy.

The study found that Keytruda reduced the risk of disease progression by greater than 40 percent and the risk of death by greater than 30 percent. The patients also suffered fewer side effects from Keytruda, researchers said.

The study leading to the FDA’s action was published in the in the New England Journal of Medicine this past April.



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The Food and Drug Administration has approved a new immunology drug for the first line treatment of patients with advanced melanoma.
FDA, melanoma, treatment, immunology, Keytruda
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2015-03-21
Monday, 21 December 2015 01:03 PM
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