FDA Approves Keytruda (pembrolizumab) for Melanoma

The US Food and Drug Administration (FDA) has approved a new kind of immunotherapy drug to treat melanoma skin cancer. Keytruda (pembrolizumab) is for patients with melanoma that’s advanced or can’t be treated with surgery, and isn’t getting better, even after treatment with other drugs.

Keytruda is a type of anti-PD-1 drug. Melanoma cells often have a protein called PD-L1 on their surface that helps them avoid being found and destroyed by the body’s immune system. Drugs that block the PD-L1 protein, or the corresponding PD-1 protein on immune cells, can help the immune system recognize the melanoma cells and attack them.

The drug is intended to be used after treatment with another immunotherapy drug called Yervoy (ipilimumab). People with a specific gene mutation called BRAF V600 should also have taken a targeted therapy drug called a BRAF inhibitor that attacks the BRAF protein directly.

The FDA approved Keytruda under its accelerated approval program for drugs that show promise against a serious disease. The company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.

The drug was tested in 173 people with advanced melanoma who were getting worse even after taking other drugs. About 1 in 4 people who took Keytruda saw their tumors shrink. The study was not designed to find out whether people taking the drug lived longer.

Keytruda is given as an infusion into the vein. The most common side effects are fatigue, cough, nausea, itchy skin, rash, decreased appetite, constipation, joint pain, and diarrhea. Less common but more serious side effects can include inflammation of the lung, colon, hormone-producing glands, liver, and other organs.

Keytruda is manufactured by Merck & Co.

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