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Positive CHMP opinion for Xtandi (enzaltamide) in additional recurrent early prostate cancer treatment setting – Astellas

Written by | 30 Mar 2024 | Oncology

Astellas Pharma Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Xtandi (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.

Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas ;”Men with nmHSPC with high-risk biochemical recurrence are very likely to experience disease progression. With approximately 9 out of 10 of these men developing metastatic disease, the need for new and effective treatment options is critical. Today’s positive opinion from the Committee is an important step forward for providing an additional treatment option for these patients and complements the existing efficacy and safety data supporting the use of XTANDI across the prostate cancer disease continuum. We look forward to XTANDI being potentially the first and only androgen receptor signaling inhibitor approved for this patient population in the European Union.”

The positive CHMP opinion is based on the results from the Phase III EMBARK trial, which were presented as a plenary session during the 2023 American Urological Association Annual Meeting and subsequently published in the New England Journal of Medicine.


“Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer”; Stephen J. Freedland, M.D., Murilo de Almeida Luz, M.D., Ugo De Giorgi, M.D., Ph.D., Martin Gleave, M.D., Geoffrey T. Gotto, M.D., M.P.H., Christopher M. Pieczonka, M.D., et al .October 19, 2023 N Engl J Med 2023; 389:1453-1465. DOI: 10.1056/NEJMoa2303974 .

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