FDA Approves Keytruda (pembrolizumab) In Advanced Melanoma Treatment

September 09-2014 – A new cancer drug has been approved by the Food and Drug Administration (FDA) to patients with advanced melanoma, the deadliest type of skin cancer. This breakthrough therapy is intended to speed up development and review of drugs aim at treating patients with serious medical conditions that don’t find notable relief from other therapeutic means.   

Last week, (September 2014), The Food and Drug Administration (FDA) of the United States has expeditiously approved Keytruda (pembrolizumab) to treat advanced melanoma, an aggressive skin cancer, in patients not responding to other treatments.

Melanoma, a very aggressive form of tumor cells responsible for skin pigmentation, representing approximately 5% of all new cancers diagnosed in the United States. According to the National Cancer Institute (NCI) in 2014, melanoma will be diagnosed in 76,000 Americans and 9,710 will die. This is the most serious form of skin cancer!

Keytruda, developed by the American company, New Jersey-based Merck & Co., is the first cancer treatment approved by the FDA (Food and Drug Administration) that targets a cellular function called PD-1(programmed cell death) that suppresses the immune system and prevents it from attacking cancer cells, says the agency in a statement.

The FDA has approved Keytruda because the results of early clinical trials have shown that this chemotherapy drug could make a significant improvement over existing therapies, the agency said.

“Keytruda is the sixth new treatment against melanoma approved by the FDA since 2011 which shows promising advances against breast cancer,” said Dr. Richard Pazdur, Director of the Office of Hematology and Oncology department of the FDA. “All of these treatments have different mechanisms of action and provide new options for patients,” he adds.

The effectiveness of Keytruda to shrink the tumor was demonstrated in a clinical trial with 173 patients with advanced melanoma who continued to progress after previous treatments.

Keytruda will be made available by month, according to a company statement. Skin cancer patients can talk to their physician about options available for them.

This is good news for patients with advanced melanoma that did not find any relief from other chemotherapies drugs and surgical therapy.

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