FDA Okays New Drug Keytruda to Treat Patients With Advanced Melanoma

The FDA panel has given a green signal to a new drug Keytruda to treat patients with advanced melanoma.

In a latest announcement, the U.S. Food and Drug Administration revealed that Keytruda (pembrolizumab) received an approval for treatment of patients with advanced or unresectable melanoma who fail to respond to other drugs.

Melanoma, a form of skin cancer, accounts for nearly 5 percent of all new cancers in the U.S. and occurs when the cancer cells form in the skin cells that make the pigment responsible for the skin color. It is estimated by the National Cancer Institute that this year, nearly 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year.

The newly-approved drug Keytruda, is the first drug approved for melanoma that blocks a cellular pathway called PD-1, which limits the immune system of the body from attacking the melanoma cells. This drug is meant to be used after treatment with ipilimumab, that is a type of immunotherapy.

In melanoma patients whose tumors express a gene mutation called BRAF V600, the drug Keytruda is meant for use after treatment with ipilimumab and BRAF inhibitor - a therapy that cubs the activity of BRAF gene mutations.

"Keytruda is the sixth new melanoma treatment approved since 2011, a result of promising advances in melanoma research," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Many of these treatments have different mechanisms of action and bring new options to patients with melanoma."

Prior to Keytruda, FDA had approved five drugs to treat melanoma called ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013) and trametinib (2013).

The new drug receives breakthrough therapy designation. It also received priority review and orphan product designation. The efficacy of the drug was tested in a clinical trial that included 173 participants.

These participants had advanced melanoma and were treated with Keytruda, either at a recommended dose of 2 milligrams per kilogram (mg/kg) or at a higher dose of 10 mg/kg. In half of the participants that received 2 mg/kg, the tumor reduced by 24 percent. The effect stayed for 1.4-8.5 months and persisted beyond this period.

The safety of the drug was tested in 411 participants with advanced melanoma. The common side effects noted were fatigue, cough, nausea, itchy skin, rash, decreased appetite, constipation, joint pain and diarrhea.

Keytruda is marketed by Merck & Co., based in Whitehouse Station, New Jersey.