Patients

FDA approves two new drugs, companion diagnostic test for advanced skin cancer

By June 7, 2013 July 7th, 2014 No Comments

Last week the FDA approved two drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with unresectable (cannot be removed by surgery) or advanced melanoma.  This type of skin cancer is the most deadly, with The National Cancer Institute estimating 76,690 new diagnoses and 9,480 deaths yearly in the U.S.  About half of all skin melanomas have a BRAF gene mutation.  The newly approved drugs are approved to treat patients whose tumors express various types of BRAF gene mutations.  The accompanying diagnostic test is called the THxID BRAF test and will help to identify which gene mutation the melanoma cells have.

Tafinlar was studied in 250 patients and showed a delay in tumor growth 2.4 months longer than the chemotherapy drug dacarbazine.  Mekinist was studied in 322 patients with a 3.3 month longer delay in tumor growth when compared to patients on chemotherapy.  Tafinlar and Mekinist are the third and fourth drugs approved for advanced melanoma within the past two years.  Read the full article here

Learn more about skin cancer prevention and sun safety from:

J. Lewis Research, Inc.

J. Lewis Research, Inc.

We are a unique research company in Salt Lake City with over 25 years of experience conducting clinical trials for the pharmaceutical industry, specializing in Phase II, III and IV clinical trials.