FDA Approves Rx for Melanoma

Keytruda granted accelerated approval to treat advanced melanoma

(RxWiki News) Some advanced melanoma patients don't respond to available medicines and cannot have surgery. Today, the US Food and Drug Administration (FDA) approved a new medicine that could help those patients.

About 5 percent of all new cancers in the US are melanoma, a type of skin cancer. This year, roughly 76,100 US patients will get it, and 9,710 will die from it, the FDA reports.

To combat melanoma in patients with advanced cases, the FDA approved Keytruda (pembrolizumab).

"Discuss new cancer treatments with your oncologist."

“Keytruda is the sixth new melanoma treatment approved since 2011, a result of promising advances in melanoma research,” said Richard Pazdur, MD, director of the FDA's Office of Hematology and Oncology Products, in a press release. “Many of these treatments have different mechanisms of action and bring new options to patients with melanoma.”

Keytruda's "mechanism of action" is unique — it is the first approved medicine that blocks PD-1, a series of proteins and molecules that stops the immune system from fighting melanoma cells.

"The drug, pembrolizumab, is part of a promising new class of antibody-based drugs that work by assisting the immune system to help identify and destroy cancer cells," said E. Lee Carter, RPh, Clinical Pharmacy Specialist at the Department of Veterans Affairs in Prestonsburg, Kentucky.

"Cases of melanoma have risen sharply, up nearly 200 percent since 1973, according to a recent 2014 study. The FDA has approved several new drugs since 2011 to fight melanoma, but Keytruda is the first drug in its class to exhibit this unique mechanism of action, earning it accelerated approval status by the FDA," Carter told dailyRx News.

"Patients diagnosed with melanoma should discuss these newer treatment options, including Keytruda, with their health care provider," he said.

Keytruda appeared effective enough in early trials to enter the FDA's accelerated approval program. The program is reserved for treatments that could offer a major improvement upon current treatments.

In one early trial, tumors shrank in 24 percent of advanced melanoma patients treated with Keytruda.

Another trial established common side effects of the medicine. These included fatigue, cough, nausea, rash, joint pain and diarrhea.

Merck & Co. markets Keytruda.

Review Date: 
September 4, 2014