Bayer's Nubeqa (Darolutamide) Gains New Indication for Metastatic Hormone-Sensitive Prostate Cancer in China's Updated National Reimbursement Drug List

On December 13, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security issued the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2023)" (hereinafter referred to as the new edition of the medical insurance catalog). Bayer's prostate cancer treatment drug, a novel androgen receptor inhibitor (ARi) Nubeq (darolutamide tablets), has successfully been renewed and received additional indications. In 2021, Nubeq was approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis and was included in the national medical insurance catalog in the same year. In March this year, the new indication for Nubeq combined with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) was approved in China. This successful inclusion in the 2023 edition of the national medical insurance catalog means that more prostate cancer patients across various stages of the disease in China will benefit from this innovative product. The new edition of the medical insurance catalog will take effect on January 1, 2024.

In recent years, the incidence and mortality of prostate cancer in China have shown a continuous upward trend. According to GLOBOCAN data, in 2020, there were 115,000 new cases of prostate cancer and 51,000 deaths due to prostate cancer in China, ranking sixth in the incidence of malignant tumors among Chinese men and seventh in mortality. The overall prognosis for prostate cancer patients in China lags significantly behind that of Western countries, with more than 50% of patients presenting with metastasis at initial diagnosis, and the five-year survival rate for metastatic patients is less than 30%.

Professor Dingwei Ye from the Fudai University-affiliated Cancer Hospital introduced: "Metastatic hormone-sensitive prostate cancer (mHSPC) is a key stage in the treatment of prostate cancer. If not properly treated at the mHSPC stage, it will quickly progress to metastatic castration-resistant prostate cancer (mCRPC), with the annual all-cause mortality rate surging from 16% to 56%. Delaying disease progression, improving survival, and maintaining patients' quality of life are important goals for mHSPC treatment." In March this year, Nubeqa was again approved for use in combination with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). It is also currently the only second-generation ARi approved for use in combination with chemotherapy, further broadening its indications for prostate cancer. Nubeqa has a more unique molecular structure compared to other novel ARis, with higher AR affinity, stronger anti-tumor activity, sustained PSA response rates reaching 71%, and higher medication safety. The ARASENS study results showed that initiating Nubeqa in combination with ADT and administering docetaxel within six weeks significantly reduced the risk of death by 32.5% in mHSPC patients compared to the control group. Notably, the Nubeqa package insert mentions that for mHSPC patients receiving dual-agent initiation or triple-agent addition therapy, the first cycle of docetaxel should be administered within six weeks of starting Nubeqa. Even if there are delays, pauses, or discontinuation of docetaxel treatment cycles, darolutamide administration should continue until disease progression or unacceptable toxicity occurs. Additionally, the package insert clearly states that the median maximum decrease in PSA from baseline in the Nubeqa treatment group was as high as 99.7%, improving patient survival. The CSCO Prostate Cancer Diagnosis and Treatment Guidelines have also recommended darolutamide as a Level I treatment option for mHSPC patients (Class IA evidence).

Bayer Oncology Business Unit General Manager Han Shuang said: "Nubeqa has been approved for indications in both non-metastatic and metastatic prostate cancer, while clinical development programs are being conducted globally to expand the treatment scope of Nubeqa to earlier stages; Radium-223 dichloride (Xofigo), as the only precision bone-targeted alpha radionuclide therapy with proven survival benefits, delays bone metastasis in prostate cancer and postpones disease progression. Nubeqa and Xofigo together contribute to the comprehensive management of prostate cancer patients in China. As an innovative treatment drug that is highly effective and safe, Nubeqa’s full range of indications have successfully been included in the National Reimbursement Drug List (NRDL), continuing to serve prostate cancer patients across broader stages of the disease in China. Bayer will always remain patient-centered, focusing on addressing unmet medical needs through innovation while actively supporting government policies and measures aimed at benefiting patients through medical insurance. We will continue to deliver innovative outcomes that benefit patients, enabling more Chinese patients to truly benefit from high-quality treatments."