BERLIN (dpa-AFX) - Bayer may soon be able to sell its prostate cancer drug Nubeqa in the EU in another indication. The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of the active ingredient darolutamide (trade name Nubeqa) in combination with chemotherapy for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), the pharmaceutical and agrochemical company said Friday. Typically, approval follows a committee recommendation. Nubeqa is already approved for the treatment of patients with non-metastatic castration-resistant prostate cancer at high risk of developing metastases (high-risk mCRPC).

In September 2022, Bayer had submitted new trial data on the drug to support its efficacy. According to the data, the drug, darolutamide, improved overall survival in patients with mHSPC and prolonged the time to worsening disease-related symptoms and pain.

Nubeqa is approved in many countries for the treatment of patients with nmCRPC at high risk of developing metastases. For mHSPC, the drug has already been approved in the U.S. and is now expected to be approved soon in the EU. Applications in China and Japan are ongoing.

The pharmaceutical and chemical company calculates peak sales of more than three billion euros for Nubeqa, the highest sales in a single year./mis/men/jha/