Roche, angling for third place among companies in the growing field of immuno-oncology, is touting promising early data for its so-called checkpoint inhibitor in skin cancer, building its case for the wide use of its in-development therapy.
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.
Amgen is now months away from a likely European approval with a first-of-its-kind cancer therapy, securing a positive opinion from a key regulatory group.
Partners Merck and Incyte are broadening their oncology alliance, moving into Phase III with a pair of treatments that use the body's natural defenses to fight cancer.
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.
Bristol-Myers Squibb has pulled the covers off of impressive Phase III data on Opdivo (nivolumab), pointing to a 73% survival rate among advanced melanoma patients after one year of therapy compared to 42% for the long-used chemo drug dacarbazine.
Merck has won the frenzied race to secure the first FDA approval for a new breed of cancer treatment, clearing the way for a U.S. launch and a scramble for dominance in a field expected to peak at nearly $35 billion a year.
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.
Roche and biotech partner Exelixis say their melanoma-fighting combination therapy met its primary endpoint in Phase III, clearing the way for an FDA application and giving the latter company a boost in its share value.
Bristol-Myers Squibb plans to submit its closely watched cancer candidate nivolumab for FDA approval to treat melanoma next quarter, outpacing analysts' expectations and setting the stage for a duel with Merck's rival drug.