Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has accepted for review Genentech’s new drug application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) to treat patients with unresectable or metastatic melanoma harboring a BRAF V600 mutation.
Subscribe to our email newsletter
For the NDA, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of 11 August 2015.
Cobimetinib is a specific MEK inhibitor discovered by Exelixis and is now the subject of a worldwide co-development agreement between Exelixis and Genentech.
It is designed to selectively block 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.
Zelboraf was co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon, which is now a member of the Daiichi Sankyo Group. Genentech is a member of the Roche Group.
The NDA is based on data from Genentech’s Phase III coBRIM trial, 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 PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone.
The international, randomized, double-blind, placebo-controlled Phase III CoBRIM trial evaluated the safety and efficacy of 60mg once daily of cobimetinib in combination with 960mg twice daily of Zelboraf, compared to 960mg twice daily of Zelboraf alone.
In the trial, a total of 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma and previously untreated for advanced disease were given Zelboraf every day on a 28-day cycle plus either cobimetinib or placebo on days one to 21.
The company is also evaluating cobimetinib in combination with several investigational medicines, including an immunotherapy, in several tumor types such as non-small cell lung cancer, colorectal cancer, triple- negative breast cancer and melanoma.
In 2014, Roche submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the combination of cobimetinib and vemurafenib.