Roche Holding AG said that its skin cancer treatment has been granted Priority Review by the US Food and Drug Administration (FDA).
The agency has accepted and granted priority review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The drug is being developed by Genentech, part of the Roche Group, and Exelixis.
The priority review designation cuts the FDA’s decision time from a standard 10 months down to six months. The agency said that it aims to make a decision on approval by August 11 this year. However, the FDA has been known to make decisions in advance of their PDUFA date. The companies are also awaiting European approval after filing an application last September.
The NDA is based on results of the coBRIM Phase III study, which showed the MEK inhibitor cobimetinib plus Zelboraf reduced the risk of disease worsening or death by half in people who received the combination, with a median progression-free survival (PFS) of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone.
“We are pleased the FDA has accepted our application for cobimetinib in combination with Zelboraf and granted it Priority Review status,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “We look forward to working with the FDA to bring this new treatment option to people with BRAF mutation-positive advanced melanoma as soon as possible.”
Cobimetinib, discovered by Exelixis, is designed to selectively block the activity of MEK, one of a series of proteins inside cells that make up a signaling pathway that aids in regulating cell division and survival. The drug binds to MEK, while Zelboraf binds to mutant BRAF, another protein on the pathway, to interrupt abnormal signaling that can cause tumor growth.
Zelboraf has been on the market since 2011. It was the first BRAF inhibitor to be approved in the US for patients with melanoma.
Melanoma is less common, but more aggressive and deadlier than other types of skin cancer. When diagnosed early, melanoma is usually curable, however most people with advanced melanoma have a poor prognosis. The American Cancer Society estimates there will be more than 76,100 new cases of melanoma and approximately 9,700 deaths from the disease this year in the US.