Xtandi Nabs New Prostate Cancer Indication

September 17, 2014

Astellas Pharma and Medivation won a new indication for their joint cancer therapy Xtandi, allowing the drug to be given to a wider swath of men with metastatic castration-resistant prostate cancer.

The expanded approval covers men with metastatic disease who have not undergone chemotherapy. The FDA initially approved Xtandi (enzalutamide) in August of 2012 for men with mCRPC who had previously undergone chemotherapy with docetaxel.

The new indication means that men at all stages of metastatic castration-resistant disease will now be able to take Xtandi,  Astellas spokesman Tyler Marciniak said. The majority of men with mCRPC fall into this group, he said.

Approval was based on a Phase III trial that showed Xtandi taken with a testosterone-lowering hormone treatment delayed the time to chemotherapy and skeletal adverse events, as well as a reduced risk of radiographic progression or death.

The European Medicines Agency said in April it would review the drug for a similar indication. The UK’s National Institute for Health and Care Excellence agreed in July to cover the drug as an end-of-life treatment for patients who had already failed two chemotherapy regimens.

Meanwhile, the drug is being tested in a wider population of patients with prostate cancer, as well as in patients with breast cancer, Marciniak said.

He estimates Xtandi generated roughly $530 million in U.S. sales in fiscal year 2013, and $232 million as of the end of June. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.