Astellas and Medivation receive CHMP backing for prostate cancer drug

Astellas and Medivation have been granted a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval of Xtandi.

The drug – which is specified for the treatment of adult men with metastatic castration-resistant prostate cancer that has progressed on or after docetaxel therapy – has been granted a positive opinion by the CHMP based on encouraging clinical trial data.

Results from the phase III study Affirm showed that Xtandi delivered a statistically significant improvement in overall survival rates compared to placebo, as well as being generally well-tolerated.

Professor Johann de Bono of the Institute of Cancer Research and Royal Marsden NHS Foundation Trust said: "This is an important development in prostate cancer therapeutics that will provide a critically important new treatment option for patients with advanced prostate cancer."

Earlier this month, Astellas announced a new cancer collaboration with Ambrx to develop new antibody drug conjugates for oncology applications.