Apalutamide gains licence

The European Commission (EC) has licensed the second-generation oral androgen receptor inhibitor apalutamide (Erleada) for the treatment of men with nonmetastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease.

The licence is based on the results of the phase 3 SPARTAN trial, which found that median metastasis-free survival was 40.5 months in the apalutamide combined with androgen deprivation therapy (ADT) group compared to 16.2 months in the ADT alone group (hazard ratio for metastasis or death, 0.28; 95% confidence interval, 0.23 to 0.35; p<0.001).

Apalutamide was generally well tolerated compared to placebo. Adverse effects included hypertension (14.3% in the apalutamide group versus 11.8% with placebo), rash (5.2% versus 0.3%), fall (1.7% versus 0.8%) and fracture (2.7% versus 0.8%). Treatment discontinuation due to adverse events was 10.6% in the apalutamide group compared to 7% in the placebo arm.

Dr Simon Chowdhury, Consultant Medical Oncologist, Guy’s and St Thomas’ Hospitals, says: ‘Apalutamide is one of the first treatments shown to be effective in this group of patients, as phase 3 clinical data demonstrated that it significantly prolonged the time that patients with non-metastatic castration-resistant prostate cancer survived without their cancer becoming metastatic.’

Whether the new drug will gain NICE approval for this indication is to be determined. An appraisal is scheduled for later this year. Enzalutamide (Xtandi) and abiraterone (Zytiga) have so far not been approved by NICE in this indication.

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