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Home Industry News Astellas applies for pre-chemo Xtandi approval

Astellas applies for pre-chemo Xtandi approval

19th March 2014

Astellas and Medivation have revealed they have submitted a supplemental New Drug Application to the US Food and Drug Administration (FDA) in an effort to widen the scope of the jointly-developed Xtandi prostate cancer treatment.

The firms said they are seeking approval to market the drug – also known under its chemical name enzalutamide – for patients with metastatic castration-resistant prostate cancer (mCRPC) who have not yet received chemotherapy.

If permission is granted by the FDA, this would mean patients could have access to the drug at an earlier stage. Currently, it is only approved for use in those who have previously been administered with docetaxel chemotherapy.

At the basis of the application is the results from the phase III PREVAIL trial, which assessed Xtandi and a placebo in more than 1,700 patients with mCRPC. The results showed the treatment reduced the risk of death by 29 per cent. 

Astellas and Medivation said an application to extend the use of the drug to pre-chemo patients in Europe will also be submitted to the relevant regulators later this year.ADNFCR-8000103-ID-801704484-ADNFCR

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