FDA Approves Keytruda for Melanoma
In its latest statement, the United States Food and Drug Administration has announced its approval of Keytruda for treating patients that have unresectable or advanced melanoma who do not respond to other treatment.
Melanoma is a type of skin cancer and accounts for close to 5% of all new cancer diagnosis in the United States. It occurs when cells that are cancerous form within skin cells that are responsible for making the pigment for the color of skin.
Officials estimate that in 2014 close to 76,100 Americans will be given the diagnosis and that over 9,700 will die this year from the cancer.
Keytruda is the first approved drug for melanoma capable of blocking PD-1 a cellular pathway, which limits the body’s immune system from attacking the cancerous cells.
The new drug is to be used following treatment using ipilmumab, a form of immunotherapy.
In patients with melanoma whose tumors have the gene mutation BRAF V600, Keytruda is to be used following treatment with a BRAF inhibitor and ipilimumab.
Keytruda is now the sixth new treatment for melanoma approved by the FDA since 2011. Many of the new treatments have varying form of action that bring new options to the patients with melanoma said the FDA.
Before Keytruda, the FDA approved five other drugs to treat the cancer: ipilimumab in 2011, peginterferon alfa in 2001, vemurafenib in 2011, dabrafenib in 2013 and trametinib in 2013.
The newly approved drug has been given a designation of breakthrough therapy, as well as orphan product and priority review designation. The drug’s efficacy was tested through a clinical trial with 173 participants.
These participants all had been diagnosed with advanced melanoma and treated using Keytruda.
The drug’s safety was tested through a study with 411 participants that also had advanced melanoma.
The side effects most common were cough, nausea, fatigue, rash, itchy skin, constipation, diarrhea, joint pain and decreased appetite.
Merck & Co. markets Keytruda and is based in New Jersey.