Keytruda = Breakthrough Therapy, Priority Review, and Orphan Product Designation

Keytruda, a new drug intended for use after ipilimumab immunotherapy and a BRAF inhibitor, blocks a specific cellular pathway that restricts the immune system from attacking melanoma cells. The drug demonstrated “substantial improvement over available therapies” and therefore received the FDA’s accelerated approval. Clinical evidence showed both safety and efficacy.

In patients who had experienced disease progression while on other treatments, Keytruda reduced tumor size in a quarter of those studied, with results lasting at least 1 to 8 months. In the past few years, melanoma research has resulted in 4 approved melanoma treatments. Because of the various mechanisms of action of these drugs, patients have more options now than ever. Keytruda (pembrolizumab) will be used when other drugs are no longer working for people with melanoma that is advanced or can’t be surgically removed.

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