EMA validates Type II variation for Astellas' Xtandi

The European Medicines Agency (EMA) has validated Japanese pharma major Astellas Pharma’s (TYO: 4503) Type II variation for Xtandi (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.

Partnered with US pharma giant Pfizer (NYSE: PFE), Xtandi is already a top-selling pharmaceutical product, well ahead of rival prostate cancer option Erleada (apalutamide), from Johnson & Johnson (NYSE: JNJ).

Commenting on the news, Dr Ahsan Arozulla, Astellas’ senior vice president and head of oncology development, said: “As the most commonly diagnosed cancer in men in Europe, prostate cancer impacts hundreds of thousands of patients across the continent, and for those who have received initial curative treatment, a risk remains that their cancer may return in the form of biochemical recurrence. These patients, particularly those with rapidly rising PSA levels, need new therapeutic approaches. The validation of the Type II variation by the EMA marks an important step toward potentially making Xtandi, an existing standard of care for advanced prostate cancer in the EU, available to patients with earlier stages of the disease who are at risk of their cancer spreading.”