Astellas receives CHMP backing for Xtandi prostate cancer approval

Astellas' cancer drug Xtandi has been recommended for European approval in a new prostate cancer indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the potential approval of Xtandi for the treatment of adult men with metastatic castrate-resistant prostate cancer.

Specifically indicated for patients who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy, and in whom chemotherapy is not yet clinically indicated, the drug has demonstrated its efficacy in clinical studies.

In the phase III trial PREVAIL, Xtandi reduced the risk of death by 29 percent versus placebo, while also cutting the danger of of radiographic progression or death by 81 percent.

Professor Bertrand Tombal, chairman of the urology division and professor of physiology at the Universite Catholique de Louvain, said: "It is my hope that the European Commission follows this opinion, providing us with a viable new treatment option for those patients not suitable for chemotherapy."

Earlier this month, the company announced that it will be collaborating with a Harvard Medical School investigator to study new treatments for retinal degeneration.