- A committee of the European Medicines Agency (EMA) recommended the expanded approval of Bayer's ( OTCPK:BAYZF ) ( OTCPK:BAYRY ) prostate cancer drug Nubeqa.
- The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Nubeqa to treat metastatic hormone?sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy.
- The European Commission, which generally follows the opinion of the EMA's CHMP, will now decide on the change to the terms of the marketing authorization of the drug.
- Nubeqa is already approved in the EU to treat non?metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
For further details see:
EMA panel backs expanded approval of Bayer's prostate cancer drug Nubeqa