Posted by Michael Wonder on 17 Nov 2018
Janssen receives positive CHMP opinion for Erleada (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease
16 November 2018 - Approval is based on Phase 3 SPARTAN clinical study data which showed apalutamide decreased the risk of distant metastasis or death by 72 percent and improved median metastasis-free survival by more than two years.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the CHMP of the EMA has issued a positive opinion for apalutamide, a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease.
The CHMP’s positive opinion will now be reviewed by the European Commission, which has the authority to grant approval for the use of apalutamide.
