German pharmaceutical giant Bayer AG (ETR: BAYN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its drug Nubeqa (darolutamide). The drug, which was previously approved for use in non-metastatic castration-resistant prostate cancer (nmCRPC) in February 2021, can now be used to treat metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
Mechanism of Action and Clinical Benefits
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity. This mechanism inhibits the receptor function and the growth of prostate cancer cells. The drug’s low potential for blood-brain barrier penetration, supported by preclinical models and neuroimaging data in healthy humans, contributes to its safety profile. In the Phase III ARAMIS trial, darolutamide significantly reduced PSA by more than 90% and had a lower overall incidence of central nervous system (CNS) related adverse events. Additionally, in the Phase II ODENZA trial, darolutamide significantly improved speech habits and memory.
Global Approval and Market Potential
Nubeqa is approved under the brand name in more than 80 countries worldwide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. It is also approved for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in several markets, including the U.S., Japan, EU, and China. Bayer is currently filing or planning filings in other regions and expects the drug’s sales peak to exceed EUR 3 billion.-Fineline Info & Tech
