Bayer AG (ETR: BAYN) has announced the submission of a supplemental new drug application (sNDA) for its Nubeqa (darolutamide) to the National Medical Products Administration (NMPA) in China. The German pharmaceutical giant is seeking approval for its androgen receptor inhibitor (ARi) combined with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). This marks the third indication filing for the drug in China.
Previous Approvals and Study Results
Nubeqa was previously approved in China for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of metastasis and for mHSPC when combined with docetaxel in February 2021 and May 2023, respectively. The latest filing is supported by positive results from the Phase III ARANOTE study, which assessed the efficacy and safety of darolutamide combined with ADT in mHSPC.
Study Details and Findings
The ARANOTE study, co-developed by Finnish pharma Orion Corporation, recruited a total of 669 patients. The results showed that the darolutamide/ADT combination significantly improved radiographic progression-free survival (rPFS) compared to placebo combined with ADT. Additionally, the treatment emergent adverse events (TEAEs) rate was lower in patients treated with the darolutamide/ADT combination, confirming its safety profile consistent with previous findings.
Significance of the Application
The submission of the sNDA underscores Bayer’s commitment to expanding the therapeutic applications of Nubeqa and providing more treatment options for patients with prostate cancer. This development highlights the potential of Nubeqa to improve patient outcomes and enhance the management of metastatic hormone-sensitive prostate cancer.-Fineline Info & Tech
