Astellas seeks new Xtandi indication

Share this article:

Astellas and Medivation have made pursuit of a pre-chemo indication for Xtandi official: the two companies announced Tuesday that they have filed a supplemental New Drug Application with the FDA so the oral drug can be used by metastatic castration-resistant prostate cancer patients earlier in treatment.

The drug is currently approved for patients who have already received docetaxel. The companies released the Phase-III data that is the basis of Tuesday's submission in January. The data indicated that an earlier intervention bought patients progression-free time.

Phase-III results also indicated that prostate-specific antigen levels fell by at least 50% among 75% of the test group, and overall survival was 29% greater with pre-chemo use compared to placebo.

Adding a pre-chemo indication to a post-chemo drug is not a new strategy: Roche moved its breast cancer drug Perjeta into first-line treatment for early stage breast cancer patients in September.

Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Imbruvica lassoes CLL indication

The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.

FDA asks social media "how'm I doin?"

The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.

Reckitt Benckiser wants out of pharma

The company plans to spin off its pharmaceutical unit.