Melanoma Research Alliance Hails FDA's Approval Of Combination Therapy For Advanced Melanoma

The Melanoma Research Alliance (MRA) hails the approval of yet another treatment for melanoma by the U.S. Food & Drug Administration (FDA). The latest approved therapy is the combination of Roche's vemurafenib (Zelboraf) and cobimetinib (Cotellic) for the treatment of patients with advanced metastatic melanoma.

Vemurafenib was approved as a single agent in 2011, the year in which some of the latest melanoma therapies first came to market after decades of stagnation. About half of all melanomas have a BRAF mutation. Vemurafenib specifically targets the V600E-mutated BRAF protein.

Cobimetinib is a MEK inhibitor. MEK, which helps regulate cell growth, is part of a signaling pathway that includes BRAF. A BRAF mutation and other molecules signal cells via MEK to develop abnormally and divide out of control. These cells can grow into a melanoma tumor.

“This news is a testament to the power of precision medicine, and demonstrates how far we’ve come in our understanding of melanoma and related biomarkers,” said Robin Davisson, Ph.D., MRA’s President and CEO-Elect.

The FDA’s decision to approve vemurafenib and cobimetinib was based on data from an international study known as coBRIM. The study included nearly 500 patients whose melanoma had either a BRAF V600E or V600K mutation, which showed that patients receiving the combination achieved better outcomes than those on vemurafenib alone.

“As we continue to fund translational research to understand the genetics of melanoma, our approaches to treatment have become more sophisticated, as evidenced by this latest approval of the combination targeted therapy,” said Louise M. Perkins, Ph.D., MRA’s Chief Science Officer.

The announcement marks the 11th therapy approved by the FDA since MRA’s founding in 2007.

“It’s really remarkable how many more treatment options patients with melanoma have today compared with just a few years ago,” added Debra Black, MRA Co-Founder and Chair of the Board. “But our work is far from done, as there are still many patients who aren’t seeing benefit from all of these new therapies, making it all the more important that we continue to press forward in our fight against melanoma.”

Since MRA launched in 2007, both targeted and immune-based therapies have been approved to treat melanoma, drastically changing the outlook for patients with melanoma and other cancers. MRA has funded research for all of these therapies, investing more than $60M for treatment-related research.

About The Melanoma Research Alliance (MRA)
MRA is a public charity formed in 2007 under the auspices of the Milken Institute, with the generous founding support of Debra and Leon Black. MRA is the largest private funder of melanoma research and has provided nearly $68M to research seeking to better prevent, diagnose, and treat melanoma, the deadliest type of skin cancer. Due to the ongoing support of its founders, 100% of every dollar MRA raises goes to support its melanoma research program. MRA’s ability to fund wide-ranging research in melanoma is amplified by unique collaborations and partnerships with individuals, private foundations, and corporations. For more information, visit www.CureMelanoma.org.