Just weeks after announcing a fresh batch of promising Phase III data, the FDA has handed Genentech and its biotech partner Exelixis an approval to market cobimetinib in combination with Zelboraf among a genetically defined group of melanoma patients.
Genentech has added another piece of the trial puzzle for its MEK inhibitor cobimetinib. The big Roche subsidiary's partner Exelixis announced early Tuesday that the drug combined with Zelboraf hit the mark in a Phase III study, offering a statistically significant overall survival benefit among advanced melanoma patients carrying a BRAF V600 mutation.
GlaxoSmithKline is touting stellar Phase III results for an in-development combo therapy for melanoma, saying its treatment beat out Roche's Zelboraf in overall survival and led independent advisers to recommend an early end for the study.
Now that targeted therapies like Roche's Zelboraf and Bayer's Stivarga have raced through the FDA and into patients' hands, drug developers are relying less and less on old-fashioned randomized controlled trials.
Hopes for a quick one-two punch against melanoma have hit a snag. A Phase I trial testing Bristol-Myers Squibb's Yervoy and Roche's Zelboraf in melanoma patients was stopped after signs of liver toxicity developed in several patients.
Skin cancer drugs from Roche and Bristol-Myers Squibb, which can provide some relief to patients with deadly skin cancers and which have big futures for sales, have finally made it past the U.K. price watchdog NICE. But this only came to pass after both companies offered undisclosed discounts to the National Health Service.
Watch out, oncology drugmakers. Memorial Sloan-Kettering Cancer Center has made a move that could crimp your ambitions for premium pricing. The leading hospital says it will exclude Sanofi's ($SNY) new colorectal cancer drug Zaltrap from its treament protocols--because its price is twice as high as competing treatments, but has proven no more effective than its rivals, namely Roche's ($RHHBY) Avastin.
Will Abraxane join the new gang of melanoma fighters?
Will Abraxane join the new gang of melanoma fighters? The Celgene ($CELG) drug, a reformulated version of the chemo drug paclitaxel, kept the cancer at bay for longer than the standard chemotherapy, dacarbazine, a new study found.
A new market report says Yervoy from Bristol-Myers Squibb ($BMY) and Zelboraf from Roche ($RHHBY) have sewn up two-thirds of the market for treating advanced malignant melanoma and will underpin significant growth in sales in developed markets for a decade.