Astellas Receives Positive CHMP Opinion for XTANDI™ (enzalutamide) for Patients with Metastatic Hormone-Sensitive Prostate Cancer
March 26, 2021 at 08:27 AM EDT
TOKYO, March 26, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an additional indication for the oral once-daily therapy XTANDITM (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).1 Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years, underscoring the need for new treatment options.2
If approved by the European Commission (EC), enzalutamide will be the only oral treatment approved by the EC to treat three distinct types of advanced prostate cancer — non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mHSPC.3 The CHMP decision is based on data from the pivotal Phase 3 ARCHES trial investigating enzalutamide in men with mHSPC.4
"This positive opinion from the CHMP is testament to our continuing commitment to addressing unmet needs for men with advanced prostate cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. "We are excited to be another step closer to approval of enzalutamide for the treatment of men with metastatic hormone-sensitive prostate cancer in Europe."
Data from the ARCHES trial showed that enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mHSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval (CI): 0.30-0.50]; P<0.0001).4
The safety analysis of the ARCHES trial appears consistent with the safety profile of enzalutamide in previous clinical trials in CRPC. In ARCHES, Grade 3 or greater adverse events (AEs) (defined as severe/disabling or life-threatening) were similar for patients receiving both enzalutamide plus ADT and those who received placebo plus ADT (24.3% vs. 25.6%).4
The positive opinion from the CHMP will now be reviewed by the EC, which has the authority to approve medicines for European Union member countries, as well as Iceland, Norway and Liechtenstein.5
Enzalutamide is currently approved in the EU for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) and adult men with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not yet clinically indicated, or following disease progression on or after docetaxel therapy.3 In the U.S., enzalutamide is approved in non-metastatic and metastatic CRPC as well as metastatic castration-sensitive prostate cancer (mCSPC) also referred to as mHSPC.6 In Japan, enzalutamide is indicated for the treatment of prostate cancer with distant metastasis, which includes mHSPC and CRPC.7,8
About metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
About XTANDI™ (enzalutamide)
Important Safety Information
About the Pfizer/Astellas Collaboration
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Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
1 European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) September 2019. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-march-2021. Last accessed March 2021.
2 Mottet N, et al. Updated Guidelines for Metastatic Hormone-sensitive Prostate Cancer: Abiraterone Acetate Combined with Castration Is Another Standard. Eur Urol. 2018;3:316-321.
3 European Medicines Authority. Summary of Product Characteristics: Xtandi 40 mg soft capsules. Available at: https://www.medicines.org.uk/emc/product/3203/smpc. Last accessed March 2021.
4 Armstrong A, et al. Phase 3 study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): the ARCHES trial. J Clin Oncol. 2019;7:687.
5 European Medicines Agency. Authorization of medicines. Available at: https://www.ema.europa.eu/about-us/what-we-do/authorisation-medicines. Last accessed March 2021.
6 Food and Drug Administration. Highlights of prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203415s015lbl.pdf. Last accessed March 2021.
7 Pharmaceuticals and Medical Devices Agency. Summary of Investigation Results Enzalutamide. Available at: https://www.pmda.go.jp/files/000232289.pdf. Last accessed March 2021.
8 Astellas Press Release. XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis. Available at: https://www.astellas.com/system/files/news/2020-05/20200529_en_1.pdf. Last accessed March 2021.
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