Astellas Receives EU Approval for Enzalutamide in Recurrent Early Prostate Cancer, Reducing Risk of Metastasis or Death by 58%

Apr 24, 2024 14:36 CST Updated 14:36

Astellas

Pharmaceutical R&D Manufacturer

▎Edited by the WuXi AppTec content team

Today (April 24), Astellas（Astellas）Announce that the European Commission (EC) has approved the new indication marketing application for enzalutamide (Xtandi), as a monotherapy or in combination with androgen deprivation therapy (ADT), for patients unsuitable for salvage radiotherapy.High-risk biochemical recurrence (BCR), non-metastatic hormone-sensitive prostate cancer (nmHSPC) in adult males。This makes the approved indications for this productCoverageTreatment of Recurrent Early Prostate Cancer。This indication for enzalutamide was approved by the U.S. FDA in November 2023.

In patients with nmHSPC, conventional radiological methods cannot detect evidence of cancer spreading to distant parts of the body, and the cancer remains responsive to drugs or surgical treatments aimed at lowering testosterone levels. It is estimated that 20% to 40% of male patients who have undergone radical prostatectomy, radiation therapy, or both will experience BCR within 10 years.Approximately 90% of high-risk BCR patients will progress to metastatic disease, and one-third will die from metastatic prostate cancer.

Enzalutamide is an androgen receptor (AR) signaling inhibitor. It not only blocks the binding of androgens to the receptor but also inhibits the receptor's translocation into the cell nucleus, as well as the binding of the androgen receptor to DNA. Therefore, it is not only an antagonist of the androgen receptor but also has an inhibitory effect on the androgen signaling pathway.EnzalutamidePreviously approved in the EU for the treatment of three different forms of advanced prostate cancer (Non-metastaticAndMetastaticCastration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer).The approval for the treatment of high-risk BCR nmHSPC extends the product's approved indications to cover recurrent early-stage prostate cancer treatment.。

According to the press release from Astellas,Enzalutamide Approval This TimeBased on the results of the Phase 3 EMBARK trial conducted in 1,068 high-risk BCR nmHSPC patients,These patients' prostate-specific antigen (PSA) levels doubled within 9 months or less (i.e., high-risk BCR).PSA is a biomarker of prostate cancer activity. Studies have shown that, compared with patients treated with leuprolide alone,EnzalutamideUnitedLeuprolidePatients TreatedThe probability of cancer spreading or death decreased by 57.6%.; Accepted individuallyEnzalutamideThe risk for participants in the treatment group was reduced by 36.9%.The results of the EMBARK trial were previously published in The New England Journal of Medicine (NEJM）。

In China,Enzalutamide has previously been approved for the treatment ofMetastatic Castration-Resistant Prostate Cancer (mCRPC)AndNon-metastatic Castration-Resistant Prostate Cancer (nmCRPC)Patient. In September 2023, the new indication application for the drug was approved by China's NMPA.Acceptance，Used forTreatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)。

References:

[1]Astellas’ XTANDITM (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting. Retrieved Apr 24， 2024, from https://www.astellas.com/en/news/29146

[2] Xtandi™ Approved by the European Commission for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer in Male Patients. Retrieved May 14, 2021, from https://mp.weixin.qq.com/s/3aAgUNZ-wr-gb0e1mKAj5w

[3]Freedland SJ, et al. Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2023;389:1453-146.

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