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.
The European Medicines Agency is moving toward approving a trio of novel medicines from Roche, Boehringer Ingelheim and Gilead Sciences, handing down positive recommendations for each.
Exelixis notched a crucial clinical success for its top oncology prospect, meeting its goals in a kidney cancer trial and clearing the way for a lucrative FDA nod.
The FDA has opted to delay its review of cobimetinib in order to give regulators more time to consider additional Phase III data provided by Genentech.
Roche and Exelixis are one step closer to FDA approval for their skin cancer-treating combination treatment, as the agency has accepted their application and promised a speedy review.
Partners Roche and Exelixis are making their case to regulators with a melanoma-treating combination therapy, filing an FDA application for the fast-tracked treatment as they await European clearance.
Welcome to the hall of shame, where blockbuster drug projections go to die. This list includes some drugs that clearly should never have wound up in Phase III to begin with, a few that were steered back to the clinic in a doomed attempt to mine something positive, and a couple of notable exceptions that may have helped advance the field by exploring the outer limits of new drug technology.
Cancer drugmakers often work to expand the labels for their marketed products by testing them in different types of the disease. But that doesn't always go so well, which can take a hefty toll on smaller companies, as San Francisco-based Exelixis now knows all too well.
Late on Monday evening Exelixis put out the word that its crucial late-stage study of cabozantinib flunked a comparison study with prednisone for castration-resistant prostate cancer, triggering a restructuring that will eliminate 70% of the jobs at the biotech.