Astellas’ Xtandi wins EU nod for earlier use in prostate cancer
24 Apr 2024
Phase 3Clinical ResultDrug Approval
The European Commission greenlit Astellas’ Xtandi (enzalutamide) with or without androgen deprivation therapy (ADT) for treating patients with high-risk biochemical recurrence (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) ineligible for salvage radiotherapy.
The clearance announced Tuesday comes close on the heels of a favourable opinion adopted by the European Medicines Agency's (EMA) drug advisory body last month. “This expanded approval for Xtandi is a vitally important advance for patients with nmHSPC with high-risk BCR,” positioning it “as a new option for treatment in the early…setting,” said Ahsan Arozullah, head of oncology development at Astellas.
The timing of the decision also coincides with the recently revised European Association of Urology (EAU) guidelines recommending Xtandi alone or with ADT as a new standard-of-care in this setting, following radiotherapy or surgery.
The approval was backed by findings from the Phase III EMBARK study, which involved 1068 patients. Results showed that treatment with Xtandi plus leuprolide led to a significant 58% reduction in the risk of metastasis or death compared with leuprolide alone. The risk reduction was 37% in patients receiving Xtandi monotherapy.
Xtandi, co-marketed by Pfizer in the US, secured FDA approval for the same indication in November and has previously been authorised for treating metastatic hormone-sensitive prostate cancer, as well as metastatic and non-metastatic castration-resistant prostate cancer.
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