On March 26, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported 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) (Press release, Astellas, MAR 26, 2021, View Source [SID1234577199]).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

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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)
In men with prostate cancer, the disease is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body. Men are considered hormone- (or castration-) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels. mHSPC has a median survival of approximately 3–4 years for men starting treatment with ADT.2

About XTANDI (enzalutamide)
Enzalutamide is currently indicated in the EU for:3

the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC);
the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated; and
the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Important Safety Information
For important Safety Information for enzalutamide please see the full Summary of Product Characteristics at: View Source

About ARCHES
The company-sponsored, Phase 3, randomized, double-blind, placebo-controlled, multinational ARCHES trial (NCT02677896) enrolled 1,150 patients with mHSPC at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region. Patients in the trial were randomized to receive enzalutamide 160 mg daily or placebo and continued on a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or had a history of bilateral orchiectomy. The primary endpoint of the trial was radiographic progression-free survival (rPFS) assessed by blinded independent central review. rPFS was defined as the time from randomization to radiographic disease progression at any time or death within 24 weeks after study drug discontinuation. Radiographic disease progression was defined by identification of two or more new bone lesions on a bone scan with confirmation (Prostate Cancer Working Group 2 criteria) and/or progression in soft tissue disease. Patients were stratified by volume of disase (low vs high) and prior docetaxel therapy for prostate cancer (no prior docetaxel, 1-5 cycles, or 6 prior cycles).4