News & Press

FDA Approves New Targeted Therapy Combination (Vemurafenib and Cobimetinib) to Treat Advanced Melanoma

Today, the FDA approved the targeted therapy combination of vemurafenib (Zelboraf®) with cobimetinib (Cotellic) for people who have advanced or metastatic melanoma and who test positive for the genetic mutation, BRAF V600.

Statement from Tim Turnham, Executive Director,           Melanoma Research Foundation

Washington, DC—Today the FDA approved a new treatment for people with melanoma, vemurafenib (Zelboraf®) combined with cobimetinib (Cotellic). Today’s approval means that people who have advanced melanoma and test positive for the most common genetic mutation in melanoma, BRAF V600, have a new option available to help stop their cancer from progressing.  
Genentech’s vemurafenib was approved in 2011 as a stand-alone treatment for BRAF V600E mutant melanoma that cannot be removed by surgery. Cobimetinib, a MEK inhibitor, is being developed through a collaboration between Genentech and Exelixis. Data showed that patients treated with the combination experienced a median of 12.25 months with no tumor progression, compared to 7.2 months for patients on vemurafenib alone. 
About half of all melanoma patients have tumors with the BRAF mutation and are candidates for the new combination therapy. Combining treatments that block BRAF and MEK has proven advantageous, as seen in the earlier approval of dabrafenib (Tafinlar®) and trametinib (Mekinist®). Combining agents with these two points of action increases response time, increases the level of this response and results in fewer side effects. This new combination provides more options for patients with the BRAF mutation. 
Drugs like vemurafenib and cobimetinib are targeted therapies, designed to interfere with the specific molecules that are driving the growth and spread of melanoma tumors. Targeted therapies, particularly combination approaches, are an important area of scientific research and progress for people with melanoma. By targeting the specific genetic “malfunction” that occurs in cancer, science is unlocking new ways to use precision in fighting tumors and help people with melanoma live longer and better lives. To learn more about targeted therapies, visit
To learn more about today’s approval of vemurafenib and cobimetinib, click here
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About Melanoma
Melanoma is one of the fastest growing cancers in the United States and can strike men and women of all ages, all races and skin types. With a one in 50 lifetime risk of developing melanoma, nearly 74,000 Americans are expected to be diagnosed with Stage I-IV melanoma and another 63,000 will be diagnosed with melanoma in situ – totaling nearly 137,000 total diagnoses. Melanoma is the most common form of cancer for young adults 25- to 29-years-old and the second most common cancer in adolescents and young adults 15- to 29-years-old. 
The majority of melanomas occur on the skin; in fact, melanoma is the most serious type of skin cancer. Melanoma can also occur in the eye (ocular, or uveal melanoma), in mucous membranes (mucosal melanoma), or even beneath fingernails or toenails. 
About the Melanoma Research Foundation
The Melanoma Research Foundation (MRF) is the largest independent organization devoted to melanoma. Committed to the support of medical research in finding effective treatments and eventually a cure for melanoma, the MRF also educates patients and physicians about prevention, diagnosis and the treatment of melanoma. The MRF is an active advocate for the melanoma community, helping to raise awareness of this disease and the need for a cure. The MRF’s website is the premier source for melanoma information seekers. More information is available at Find the MRF on Facebook and Twitter.
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