Bayer's Prostate Cancer Drug Nubeqa (Darolutamide) Receives EU Approval for nmCRPC
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The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
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On March 30, Bayer announced that the European Commission (EC) had approved its oral androgen receptor inhibitor (ARi), Nubeqa.®(darolutamide) marketing authorization for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of progressing to metastatic disease.
On January 31, darolutamide received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for its marketing authorization in the European Union. The CHMP’s recommendation and the subsequent formal approval by the European Commission were based on the results of the Phase III ARAMIS trial. ARAMIS was a randomized, double-blind, placebo-controlled, multicenter Phase III study that evaluated the efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) versus placebo combined with ADT in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were receiving ADT and at high risk for metastasis.
The results showed that the primary efficacy endpoint—metastasis-free survival (MFS)—was significantly improved in the darolutamide plus ADT group, with a median value of 40.4 months compared to 18.4 months in the placebo plus ADT group (p<0.0001). Furthermore, darolutamide combined with ADT demonstrated a favorable safety profile in this study.
In the ARAMIS trial, overall survival (OS) and time to pain progression were additional secondary efficacy endpoints. The final analysis of OS data demonstrated that darolutamide combined with androgen deprivation therapy (ADT) resulted in a statistically significant prolongation of OS compared with placebo plus ADT. Regarding time to pain progression, darolutamide combined with ADT delayed the time to pain progression compared with placebo plus ADT, providing additional support for the metastasis-free survival (MFS) results. All other secondary endpoints, including time to cytotoxic chemotherapy and time to first symptomatic skeletal event, favored darolutamide at the time of the final MFS analysis.
The most common adverse reactions (occurring ≥2% more frequently than in the control group) in the darolutamide plus ADT group were fatigue/asthenia (16% vs. 11%), pain in extremities (6% vs. 3%), and rash (3% vs. 1%). In both study groups, 9% of patients discontinued treatment due to adverse events.
Prostate cancer is the second most common malignant tumor in men worldwide and the fifth leading cause of cancer-related deaths among men. It primarily affects men over the age of 50, with the risk of developing the disease increasing with age. Treatment options include surgery, radiation therapy, and medications such as hormone receptor antagonists, which work by blocking testosterone production or preventing its action at target sites. Despite androgen deprivation therapy (ADT) reducing testosterone levels to very low levels, the disease may continue to progress, a condition known as non-metastatic castration-resistant prostate cancer (nmCRPC). In Europe, based on 2018 incidence data, it is estimated that more than 670,000 men were diagnosed with CRPC. Approximately one-third of patients with non-metastatic CRPC develop metastases within two years.
Darolutamide is an androgen receptor inhibitor. Its unique chemical structure exhibits high affinity for receptor binding and strong antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells. This compound was jointly developed by Bayer and the Finnish pharmaceutical company Orion. Bayer is responsible for the global commercialization of the product, while in certain European markets—such as France, Germany, Italy, Spain, the United Kingdom, Scandinavia, and Finland—it is co-promoted by Bayer and Orion. Prior to receiving approval in the European Union, darolutamide had already been approved in the United States, Brazil, and Japan for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
In China, the marketing application for darolutamide (ODM-201) was accepted by the Center for Drug Evaluation (CDE) on February 15, 2020, with the acceptance number JXHS2000007. Subsequently, it was included in the priority review under category (1) of the priority review scope, as one of the three innovative drugs with significant therapeutic advantages.
In addition to the nmCRPC indication, darolutamide is also being investigated in the Phase III ARASENS trial for metastatic hormone-sensitive prostate cancer.
Reference source: Nubeqa® (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.