Astellas Announces NMPA Approval of Enzalutamide for Non-Metastatic Castration-Resistant Prostate Cancer in China

On November 4, according to the notice issued by the National Medical Products Administration (NMPA) of China regarding drug approval documents, Astellas’ enzalutamide (Xtandi) received a new approval number in China. On December 20 last year, the Center for Drug Evaluation (CDE) included the marketing application (JXHS1900163) for this drug, intended for the treatment of adult male patients with non-metastatic castration-resistant prostate cancer (nmCRPC), in the priority review program, citing it as an innovative drug with significant therapeutic advantages. The issuance of the new approval number signifies that the indication for nmCRPC has been officially approved in China!

Prostate cancer is the second most common malignant tumor in men worldwide and the fifth leading cause of cancer-related deaths among men. Current treatment options include surgery, radiation therapy, and the use of hormone receptor antagonists. However, nearly all cases eventually develop resistance to conventional hormone therapy. Castration-resistant prostate cancer (CRPC) represents an advanced form of prostate cancer, characterized by continued disease progression despite testosterone levels being reduced to very low levels. In patients with non-metastatic castration-resistant prostate cancer (nmCRPC), a rapid rise in prostate-specific antigen (PSA) levels typically indicates imminent metastasis and is associated with a poor prognosis. Statistics show that one-third of nmCRPC patients develop metastases within two years. There is an urgent need for innovative therapies to control disease progression in these patients.

In July 2018, the U.S. FDA approved enzalutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC), based on the results of the phase 3 PROSPER clinical trial. The PROSPER trial demonstrated that, compared with androgen deprivation therapy (ADT) alone, the combination of enzalutamide plus ADT significantly reduced the risk of metastasis or death, with a median metastasis-free survival (MFS) of 36.6 months versus 14.7 months (HR = 0.29 [95% CI: 0.24–0.35]; p < 0.0001). Furthermore, compared with ADT alone, the enzalutamide plus ADT combination therapy significantly prolonged the time to PSA progression (median 37.2 months versus 3.9 months) and the time to initiation of new anticancer therapy (TTA; median 39.6 months versus 17.7 months). The combination therapy reduced the risk of PSA progression by 93% (p < 0.0001) and reduced the risk of requiring new anticancer therapy by 79% (p < 0.0001).

Enzalutamide, jointly developed by Astellas and Pfizer, is a selective androgen receptor inhibitor. It not only blocks the binding of androgens to their receptors but also inhibits nuclear translocation of the receptor and suppresses the binding of the androgen receptor to DNA. Therefore, it acts not merely as an androgen receptor antagonist but also inhibits the androgen signaling pathway. Notably, enzalutamide was the first drug approved by the U.S. FDA for both metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). In November 2019, enzalutamide was first approved in China for the treatment of adult patients with asymptomatic or mildly symptomatic mCRPC who had failed androgen deprivation therapy (ADT) and had not received chemotherapy.

References:

[1] Notice on the Availability for Collection of Drug Approval Documents Issued on November 4, 2020. Retrieved 2020-11-04, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20201104145745108.html

Source: Jike Yaowen

▽Follow [WuXi AppTecDe】WeChat Official Account