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Xtandi on course for pre-chemo use in prostate cancer

US FDA grants priority review to Medivation and Astellas drug
Astellas Xtandi enzalutamide

The US FDA has granted a priority review to Medivation and Astellas as they try to expand the use of prostate cancer drug Xtandi into the pre-chemotherapy setting.

Xtandi (enzalutamide) is already approved to treat patients with castration-resistant prostate cancer (CRPC) who have already been treated with docetaxel chemotherapy, but first-line use would lend additional momentum to the drug's take-up as it competes in the market against Johnson & Johnson's Zytiga (abiraterone).

The application for Xtandi is based on the results of the PREVAIL study, which enroled more than 1,700 men with pre-chemo CRPC whose symptoms had progressed despite anti-androgen therapies such as AbbVie's Lupron (leuprolide acetate) and AstraZeneca's Casodex (bicalutamide).

The trial was stopped early last year based upon "compelling efficacy", including a 29 per cent reduction in the risk of death compared to placebo and an average 17-month delay in the start of chemotherapy, according to Medivation chief executive David Hung.

Xtandi is already becoming an important new therapy for CRPC, racking up sales of $392m in the US alone last year, its first full year on the market since debuting in September 2012, and $445m worldwide after securing approval in Europe mid-year. It was also approved in Japan in March.

Zytiga reached the market a few months ahead of Xtandi and has quickly become a big seller for J&J, with sales of $1.7bn last year. J&J's drug was approved for use in the pre-chemotherapy setting last July, but was already being used extensively off-label in that patient population.

If approved for pre-chemotherapy use, Xtandi will be able to compete head-to-head in the marketplace with J&J's drug and put the drug on course to meet its 2014 sales targets, which Medivation has said should be between $500m and $535m.

Medivation is also trying to position Xtandi earlier in the course of prostate cancer, as well as in other indications such as breast cancer.

In December the company enroled the first patient in its PROSPER trial, involving a high-risk subgroup of approximately 1,500 pre-chemo non-metastatic CRPC patients who are progressing despite anti-androgen therapy and who are asymptomatic with no evidence of metastatic disease.

Medivation also has two phase II trials comparing Xtandi with Casodex, the most widely-used anti-androgen.

Article by
Phil Taylor

8th May 2014

From: Sales



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