Astellas and Medivation today said they are asking the FDA for approval for Xtandi to be used on patients with metastatic castration-resistant prostate cancer who have not received chemotherapy.
Medivation and Astellas Pharma unveiled final results on primary and secondary efficacy endpoints from their Phase III PREVAIL trial of Xtandi (enzalutamide), showing that the drug delayed tumor growth and prolonged the lives of patients with metastatic prostate cancer who previously have not undergone chemotherapy.
Xtandi has reached a key milestone: success in a Phase III trial eyeing the drug from Medivation and Astellas as a prechemo treatment for advanced prostate cancer.
Now that the final wrap-up of Amgen's $10.4 billion buyout of Onyx is under way, analysts can get back to one of their favorite pastimes: Speculating on the next big biotech M&A deal that could make executives rich and investors' portfolios burst with big gains.
Welcome to this week's roundup of hirings and firings throughout the industry. Please send the good word (or the bad) from your shop to Alison Bryant (email | Twitter) and we will feature it...
The market for prostate cancer drugs is expected to double by 2021 to $9.1 billion, thanks in part to the debut of new, more expensive drugs. According to Decision Resources, Johnson & Johnson's ($JNJ) Zytiga, along with Medivation ($MDVN) and Astellas Pharma's new Xtandi, will help drive sales growth in 7 major drug markets.
Just days after reporting positive interim results from a mid-stage study of its closely-watched prostate cancer drug, San Diego-based Aragon Pharmaceuticals has topped up its bank account with a whopping $50 million venture round--bringing its total haul this year alone to $88 million.
Astellas Pharma and Medivation won FDA approval for their prostate cancer treatment Xtandi three months ahead of schedule. That's welcome news for them--but perhaps not so welcome for competitors, especially Johnson & Johnson, whose Zytiga pill will be Xtandi's closest rival.
Medivation won FDA approval for MDV3100 today, setting up the quick commercialization of another prostate cancer drug that will further change an already roiled cancer market. The drug, later dubbed enzalutamide and now called Xtandi, won an OK a full three months ahead of the agency's PDUFA date. Astellas is partnered on the program.
Medivation has added another set of stellar data on enzalutamide, its promising prostate cancer treatment now up for a priority review at the FDA. New late-stage results published in the New England Journal of Medicine indicate that advanced stage, therapy-resistant patients in the drug arm survived 5 months longer than the control group.