J&J: EU body backs Janssen's new prostate cancer drug

(CercleFinance.com) - European regulators on Friday issued a positive opinion on Janssen's apalutamide, a next generation oral drug for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.


The CHMP's positive opinion is based on Phase 3 data that showed that apalutamide reduced the risk of developing distant metastasis or death compared to placebo by 72%.

The CHMP's positive opinion will now be reviewed by the European Commission.

Janssen is a unit of US biopharmaceutical giant Johnson & Johnson.

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