First it was good news, then it was bad news, and now it's good news again for Astellas' prostate cancer treatment Xtandi (enzalutamide) and its recommendation from the U.K.'s National Institute for Health and Care Excellence. At least it appears that way.
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.
Some new data on the prostate cancer drug Xtandi promises to heat up competition with Johnson & Johnson's Zytiga. Medivation and its partner Astellas Pharma unveiled final data from a late-stage trial showing that Xtandi prolonged patients' lives and delayed tumor growth when used before chemotherapy.
The U.K.'s National Institute for Health and Care Excellence is known to change its mind. But this time, Britain's cost watchdog has set limitations on its recommendation for prostate cancer pill Xtandi--and maker Astellas is none too happy.
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.
Soon after Xtandi hit the market last year, analysts were figuring that the prostate cancer drug would help pump up that market to $9.1 billion by 2021. And now, the drug has shown success in a Phase III trial eyeing Xtandi as a prechemo treatment for advanced prostate cancer.
Xtandi, the prostate cancer drug from Astellas, is a pill, and that is a benefit to patients in the eyes of an independent committee for the U.K.'s price watchdog, NICE. But then, so is Johnson & Johnson's competitor Zytiga, which NICE has already approved. The difference is that Xtandi can be taken after eating, an advantage the makes it more convenient in the eyes of NICE evaluators who have favored its use in the U.K.
Herewith we bring you our Top 15 Drug Launch Superstars. Some of them will be obvious to anyone who follows the pharma business. They certainly were obvious to us. But choosing the rest was a challenge--one we weren't exactly expecting, based on previous experience. Read the full report >>
Japan's drugmakers aren't any more immune from generic competition than U.S. pharma companies are. Still the country's second- and third-largest drugmakers are predicting sales growth this year, even as low-cost copies drain away sales of their key products. New drugs are coming in to pick up the slack, the companies said.