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Keytruda: Battling Melanoma with a New FDA Approved Drug
- Updated: September 11, 2014
There is good news for people fighting the deadly skin cancer Melanoma. Researchers who have spent years working on various Melanoma studies are excited about a new drug approved by the United States Food and Drug Administration (FDA) for treating this deadly form of skin cancer.
Called Keytruda (pembrolizumab), this drug is designed to treat patients who have advanced stage Melanoma but who also no longer respond to other drugs for this purpose. This is the first drug approved by the FDA capable of blocking PD-1, a cellular pathway that restricts the immune system from attacking the deadly cancer cells.
As stated by Wendy Selig, president of the Melanoma Research Alliance, this is just one of many breakthroughs specific to the treatment of Melanoma. She believes this new drug will encourage more research on Melanoma and help in developing additional cancer treatments. Keytruda has shown serious potential for saving lives of people with late stage Melanoma, those who just a few years ago had little hope for survival.
According to the FDA, Keytruda was approved based on a clinical trial consisting of 173 patients, all with late stage Melanoma. Through the study, researchers discovered that two milligrams per kilogram of the drug resulted in tumor shrinkage in approximately 24% of the patients, which lasted a minimum of 1.4 to 8.5 months. However, continued success beyond that timeframe was seen in the majority of study participants.
Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products associated with the FDA’s Center for Drug Evaluation and Research states that Keytruda is now the sixth treatment approved by the FDA for Melanoma in the past three years due to incredible research advances. He goes on to say that many of the newly approved drugs have distinct mechanisms of action, which provides patients with Melanoma more treatments.
Tim Turnham, director of the Melanoma Research Foundation agrees with Pazdur’s statement by saying that the approval of Keytruda is a huge step in the right direction and that in fact, it is the most promising drug developed so far with excellent patient response. He went on to note that additional drugs will be approved by the FDA soon, which also targets the PD-1 pathway although he cautions that Keytrude may not be the right treatment for every Melanoma patient.
According to Turnham, while many of the patients in the study saw tremendous benefit when given Keytruda but to date, there is not a treatment capable of successfully killing cancerous cells or preventing recurrence for all patients. Obviously, this is the ultimate goal and something researchers are striving to achieve.
Marketed by Merck & Co., Keytruda will make a huge difference in the lives of people with late stage Melanoma but there are side effects to consider that includes constipation, diarrhea, joint pain, fatigue, nausea, cough, rash, itchy skin, and reduced appetite. However, considering that Melanoma accounts for 5% of all new cancer cases in America, with approximately 9,710 people dying each year, approval of this drug is a big deal.