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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to amend the marketing authorization for Astellas Pharma Europe's enzalutamide (Xtandi) to treat adult men with metastatic castrate-resistant prostate cancer (mCRPC).
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The drug secured CHMP positive opinion for treatment of mCRPC patients who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated.
The positive opinion is based on results from the Phase III PREVAIL trial which showed that men treated with enzalutamide demonstrated a statistically significant reduction both in the risk of death and a delay in cancer progression and the time to initiation of chemotherapy as compared to those treated with placebo.
Université Catholique de Louvain (UCL) Urology Division chairman and Physiology professor and European principal investigator for PREVAIL Dr Bertrand Tombal said: "For us urologists treating patients with mCRPC, this positive opinion from the CHMP is an important milestone towards making enzalutamide available across Europe.
"Enzalutamide marks a significant step for many patients who live with mCRPC as encouraging, it demonstrates benefits in overall survival, has a positive impact on quality of life and has been shown to be well tolerated.
"As well as clear efficacy and safety benefits over placebo, enzalutamide has the additional advantage of not requiring steroids to be taken concomitantly and requires only basic monitoring, making it a simple option for both healthcare professionals and patients."
The trail showed that enzalutamide reduced the risk of death by 29% as well as the risk of radiographic progression or death by 81% compared with placebo.
Currently, Xtandi is licensed in Europe to treat adult men with mCRPC whose disease has progressed on or after docetaxel therapy.