New Chometherapy Drug Approved by The FDA In Advanced Melanoma
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
(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
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
"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,"
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.