The Food and Drug Administration have approved what researchers say is a “game-changing” drug for the treatment of advanced melanoma.

Share on Pinterest A drug called Keytruda has received fast-track approval from the FDA for the treatment of advanced melanoma.

Rates of melanoma have been increasing significantly over the past 30 years. The skin cancer now accounts for around 5% of all new cancers in the US, and there are expected to be 76,100 new cases and 9,710 deaths from the disease this year.

Now, the Food and Drug Administration (FDA) have granted fast-track approval for a drug called Keytruda (pembrolizumab) – developed by pharmaceutical company Merck & Co. – to treat patients with advanced melanoma who are no longer responding to alternative treatment.

The approval is based on the results of clinical trials conducted by Dr. Antoni Ribas of the University of California-Los Angeles (UCLA) and colleagues, in which they tested the drug on more than 600 patients with advanced melanoma who had not responded to previous therapies.

In one study, the team treated 173 patients with either 2 milligrams per kilogram (mg/kg) of Keytruda or 10 mg/kg of the drug. The team found that 24% of patients who received the 2 mg/kg dosage of Keytruda experienced tumor shrinkage of more than 30%, while a smaller percentage of patients given the 10 mg/kg dose had tumor shrinkage.

The tumors did not regrow in these patients, and the drug’s effects remained for at least 1.4-8.5 months, with some patients seeing effects for even longer.

In another study testing the safety of Keytruda in 411 patients with advanced melanoma, the team found that severe side effects – such as problems with the lung, colon and liver – were rare. The most common side effects were fatigue, cough, nausea, rash, itchy skin, reduced appetite, constipation, diarrhea and joint pain.