FDA Approves Two New Drugs for Treatment of Advanced Skin Cancer-Melanoma
Posted May 29 2013 6:07pm
Tafinlar and Mekinist,are the names of the two new drugs. Mekinist,is a protein inhibitor associated with cancerous tumors. Tafinlar belongs to a class of drugs called BRAF inhibitors. There’s also a test approved by the FDA that identifies to determine of the melanoma cells have the mutations in the BRAF gene. Glaxo has a focus on skin cancer drugs and it was in 2012 they received approval of another drug that extends life for those with late stage skin cancer.
(Reuters) - U.S. health regulators on Wednesday approved a pair of GlaxoSmithKline Plc drugs to treat advanced melanoma - the deadliest form of skin cancer - in patients with specific genetic mutations. It also approved a diagnostic test to detect the mutations.
The Food and Drug Administration said it approved the drugs, Tafinlar and Mekinist, to be used as single agents and not in combination after the medicines delayed tumor growth in separate clinical trials.
Tafinlar, known chemically as dabrafenib, belongs to a class of cancer drugs called as BRAF inhibitors. Mekinist, known chemically as trametinib, inhibits a protein associated with cancerous tumors known as MEK.
The FDA also approved the THxID BRAF test, made by France's bioMérieux , which will be used to determine if a patient's melanoma cells have the V600E or V600K mutation in the BRAF gene.