Bayer's Prostate Cancer Drug Nubeqa (Darolutamide) Receives FDA Approval for Non-Metastatic Castration-Resistant Prostate Cancer

On July 31, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Bayer announced the U.S. Food and Drug Administration (FDA) had approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARI), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

Darolutamide was jointly developed by Bayer and the Finnish pharmaceutical company Orion Corporation. Bayer has already submitted marketing applications for Darolutamide in the European Union (EU), Japan, and other countries. The FDA approval was based on an evaluation of Nubeqa plus androgen deprivation therapy (ADT) in the Phase III ARAMIS clinical trial, which demonstrated a significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS). Compared with placebo plus ADT, the median MFS was 40.4 months in the Darolutamide treatment group versus 18.4 months in the control group.

Nubeqa was approved under the U.S. Food and Drug Administration (FDA) Priority Review designation, which is granted to drugs that may significantly improve the treatment of serious conditions. The new drug received FDA Priority Review status in April this year, three months ahead of the FDA’s target action date.

Darolutamide is a non-steroidal androgen receptor antagonist. It possesses a unique chemical structure that enables high-affinity binding to the androgen receptor (AR), thereby exhibiting potent antagonistic activity. Consequently, it inhibits androgen receptor function and the proliferation of prostate cancer cells.

Prostate cancer is the second most common malignant tumor worldwide and the fifth leading cause of cancer-related deaths in men. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and approximately 358,000 people died from the disease globally. Prostate cancer is caused by the abnormal proliferation of prostate cells, which are part of the human reproductive system.

Prostate cancer primarily affects men over the age of 50, with risk increasing as they age. Current treatment options include surgical intervention, radiation therapy, and the use of hormone receptor antagonists. Darolutamide can inhibit testosterone production or block its action at target sites. However, nearly all cancers eventually develop resistance to conventional hormone therapies.

Castration-resistant prostate cancer (CRPC) is an advanced form of prostate cancer in which the disease continues to progress despite androgen levels being reduced to very low levels. For patients with metastatic castration-resistant prostate cancer (mCRPC), a rapid rise in prostate-specific antigen (PSA) levels typically indicates imminent cancer metastasis, creating an urgent need for innovative therapies to control disease progression.

Robert LaCaze, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Bayer’s Oncology Strategic Business Unit, stated: “With the approval of Nubeqa, we now have a new treatment option that extends metastasis-free survival (MFS) and allows physicians greater flexibility in treating men with non-metastatic castration-resistant prostate cancer (nmCRPC). As the latest addition to our prostate cancer portfolio, Nubeqa reflects Bayer’s commitment to finding treatments for men with prostate cancer across different stages of the disease.”

Bayer, founded in 1863 and headquartered in Leverkusen, Germany, is a biotechnology and pharmaceutical company. The company operates across multiple sectors, including pharmaceuticals, healthcare, agriculture, and animal health. Bayer’s pharmaceutical division primarily produces prescription medicines in the fields of cardiology, women’s health, oncology, hematology, and ophthalmology. Additionally, Bayer has established a strategic research alliance with Kyoto University in Japan, dedicated to identifying drug targets for the treatment of pulmonary diseases such as idiopathic pulmonary fibrosis.

(Compiled by Cheng Tao)