Genentech Submits NDA to FDA for Investigational Cobimetinib Used in Combination with Zelboraf (Vemurafenib) in Advanced Melanoma
![](/46/pdcnewsitem/03/39/80/4C8aQo8g9fH7RTW.jpg)
Genentech has submitted a New Drug Application (NDA) for cobimetinib to the FDA for treatment, in combination with Zelboraf (vemurafenib), for people with BRAF V600 mutation-positive advanced melanoma. The submission is based on results of the coBRIM Phase III study, which showed people who received the MEK inhibitor cobimetinib plus Zelboraf lived significantly longer without their disease worsening or death (progression-free survival; PFS) compared with Zelboraf alone.
"In the past several years we have made significant progress in treating advanced melanoma, but it remains a serious and difficult to treat cancer that affects more people each year,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “We look forward to working with the FDA as they review the NDA and hope the combination of cobimetinib and Zelboraf will soon become a new option for people with BRAF mutation-positive advanced melanoma."
In the coBRIM study, cobimetinib and Zelboraf reduced the risk of disease worsening or death by half (hazard ratio [HR]=0.51, 95% confidence interval [CI] 0.39-0.68; p<0.0001), with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone. The safety profile was consistent with a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and lab abnormalities. The most common Grade 3 or higher adverse events in the combination arm included liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and diarrhea.
The results were presented at the European Society of Medical Oncology (ESMO) 2014 Congress and published in the New England Journal of Medicine. Roche has already submitted the coBRIM data to the European Medicines Agency.
Related News
-
News CPHI Podcast Series: the power of digital marketing in pharma
Digital marketing is a valuable tool for many industries, and the pharmaceutical and healthcare industry is no exception. The CPHI Podcast Series covers how marketing can be used by companies to increase their engagement and overcome challenges.&n... -
News Novel approach to creating sustainable packaging from rice husks
Researchers have created a new approach to the designing of eco-friendly nanofibres extracted from rice husks, addressing the critical need for sustainable packaging materials in food and biopharmaceutical products. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance