Astellas Pharma submits application for cancer drug

Astellas Pharma and Medivation have submitted a new drug application to the US Food and Drug Association (FDA) for enzalutamide requesting a priority review, a service that can be given to new products that offer a significant improvement in treatment or provide a unique form of care.

The drug could then be rolled out globally after being studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.

It is intended for work with cancer patients who have previously been given a course of chemotherapy.

With the FDA expected to make a decision in 60 days on whether to accept the filing for review, the process could be completed in six months.

Enzalutamide, taken orally, is an androgen receptor signalling inhibitor. It was well-tolerated in clinical trials, with serious adverse events causing patients to stop treatment or die less common than in the placebo group.

Astellas Pharma recently published positive data from a new clinical trial of renal cell carcinoma treatment tivozanib.