Genentech's Cobimetinib Grabs Priority Review for Advanced Melanoma
Published: Feb 20, 2015
February 19, 2015
By Riley McDermid and Krystle Vermes, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration has granted priority review status to Genentech ’s new Drug Application for cobimetinib, in combination with vemurafenib, for the treatment of BRAF. V600 mutation-positive advanced melanoma, with an announcement slated for Aug. 11.
A Priority Review designation is only given in cases where the FDA determines the drug has an immediate potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. It can mean a fast track to market, as well, and a coveted edge for drugmakers in the already crowded field of oncology.
“Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer. When melanoma is diagnosed early, it is generally a curable disease, but most people with advanced melanoma have a poor prognosis,” said Genentech in a statement. “The American Cancer Society estimates there will be more than 76,100 new cases of melanoma and approximately 9,700 melanoma deaths this year in the United States.”
Genentech, a Roche company, has been experimenting with Vemurafenib, which is sold as Zelboraf, in tandem with cobimetinib to treat the rare mutation that causes that particular form of cancer.
The two work well together because cobimetinib selectively blocks the activity of MEK, one of a series of proteins inside cells that make up a signaling pathway that helps regulate cell division and survival, while Zelboraf binds to mutant BRAF, another protein on the pathway, to interrupt abnormal signaling that can cause tumors to grow.
“We are pleased the FDA has accepted our application for cobimetinib in combination with Zelboraf and granted it Priority Review status,” said Sandra Horning, 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.
The NDA submission is based on a recent coBRIM Phase III study, which showed that people who received cobimetinib in conjunction with vemurafenib were able to live significantly longer without their disease becoming worse. This was in comparison to those who received vemurafenib alone, without cobimetinib.
Genentech conducted the Phase III trial with 495 patients who have BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma. The results of the study show that there was a significant increase in the progress-free survival rate. The average PFS was 9.9 months, compared to 6.2 months when patients took vemurafenib alone. Adverse effects were diarrhea, nausea, rash and photosensitivity.
The results of the study were shared during the Presidential Symposium at the European Society for Medical Oncology 2014 Congress gathering.
Exelixis, Inc. , a biopharmaceutical company aimed at developing small molecule therapies for cancer treatment, is responsible for discovering cobimetinib internally. It also advanced the compound to investigational new drug status.
In 2006, Exelixis entered a co-development agreement with Genentech for cobimetinib. As a result, Exelixis received upfront and milestone payments, and the company remained responsible for the development of cobimetinib through the maximum tolerated dose in phase 1.
In 2013, Exelixis exercised its option to promote cobimetinib, if approved, within the U.S. The company is also entitled to an equal share of profits and losses, which will decrease as sales increase. Additionally, Exelixis remains eligible to receive royalties on the sales of products outside of the U.S.
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