Astellas' XTANDI (Enzalutamide) Approved by European Commission for Metastatic Hormone-Sensitive Prostate Cancer
May 06, 2021 23:57
CST Updated
23:57
Astellas
Pharmaceutical R&D Manufacturer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
May 06, 2021 /BioValleyBIOON/ -- Japanese pharmaceutical company Astellas recently announced that the European Commission (EC) has approved a new indication for Xtandi (Xtandi®, generic name: enzalutamide): for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). mHSPC is also known as metastatic castration-sensitive prostate cancer (mCSPC). Men diagnosed with mHSPC often have a poor prognosis, with a median survival of 3–4 years, highlighting an urgent need for new treatment options.
With this latest approval,Xtandi has become the only oral medication currently approved in the European Union for the treatment of three different types of advanced prostate cancer: non-metastatic and metastatic castration-resistant prostate cancer (CRPC), and metastatic hormone-sensitive prostate cancer (mHSPC).
This approval is based on data from the pivotal Phase 3 ARCHS study (NCT02677896). The study enrolled a total of 1,150 patients with metastatic hormone-sensitive prostate cancer (mHSPC) to evaluate the efficacy and safety of Xtandi versus placebo, each in combination with androgen deprivation therapy (ADT).
The results showed that the study met its primary endpoint of radiographic progression-free survival (rPFS): compared with the placebo + ADT group, the Xtandi + ADT groupRadiologic Progression or Risk of Death Significantly Reduced by 61%(HR=0.39 [95% CI: 0.30-0.50]; p<0.0001). In this trial, the safety profile of Xtandi was consistent with that previously observed in CRPCClinical TrialThe safety profile was consistent, with the incidence of Grade 3 or higher adverse events (AEs) (defined as severe/disabling or life-threatening) being similar in patients receiving the Xtandi + ADT regimen and those receiving the placebo + ADT regimen (24.3% vs. 25.6%).
Prostate Cancer (Image source: hopkinsmedicine.org)
Globally, prostate cancer is the second leading cause of cancer-related death in men, following lung cancer. Prostate cancer typically occurs in older men and is often driven by excessive levels of male hormones, including testosterone (an androgen). The standard clinical approach to treatment involves reducing androgen levels in the body, which can be achieved through surgical castration and/or androgen deprivation therapy (ADT).
Metastatic prostate cancer refers to cancer cells that have spread beyond the prostate to other parts of the body (such as bones, lymph nodes, bladder, and rectum). If patients at this stage still respond to surgical or medical treatments aimed at lowering testosterone levels, the disease is considered hormone-sensitive (or castration-sensitive). For male patients with metastatic hormone-sensitive prostate cancer (mHSPC) who begin androgen deprivation therapy (ADT), the median survival time is approximately 3–4 years.
Professor Andrew Armstrong, Principal Investigator of the ARCHS study and Director of the Prostate and Urologic Cancers Program at the Duke Cancer Institute, stated, “Patients with metastatic hormone-sensitive prostate cancer (mHSPC) have limited treatment options, and unfortunately, many face a poor prognosis. The ARCHS study provides clinical evidence demonstrating that Xtandi can significantly improve outcomes in patients with mHSPC, offering healthcare professionals in Europe a therapeutic option for managing the continuum of advanced prostate cancer.”
Andrew Krivoshik, Ph.D., Senior Vice President of Astellas Oncology Development and Global Therapeutic Area Head, stated, “Xtandi has become an established standard of care for patients with advanced prostate cancer, with more than 610,000 patients treated worldwide since its initial approval in 2012. This new indication for Xtandi provides a much-needed additional treatment option for patients with metastatic hormone-sensitive prostate cancer (mHSPC). We look forward to collaborating with health authorities across Europe to ensure that patients with mHSPC can access Xtandi as soon as possible.”
Xtandi® (enzalutamide) is an androgen receptor signaling inhibitor administered orally once daily. This medication directly targets the androgen receptor (AR) and acts at three steps in the AR signaling pathway: (1) inhibition of androgen binding, where androgen binding induces conformational changes that trigger receptor activation; (2) prevention of nuclear translocation, as AR translocation to the nucleus is an essential step in AR-mediated gene regulation; and (3) impairment of DNA binding, since the binding of AR to DNA is critical for regulating gene expression.
Xtandi, launched in 2012, is a blockbuster drug in the field of prostate cancer treatment. It has been approved for multiple therapeutic indications, which vary by country, including metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC), and metastatic castration-sensitive prostate cancer (mCSPC). Notably, Xtandi is the first product approved for the treatment of three distinct types of advanced prostate cancer (nmCRPC, mCRPC, and mCSPC).
In China, Xtandi (Anketan®, enzalutamide) was approved in November 2019 and November 2020, respectively.: (1) For the treatment of asymptomatic or mildly symptomatic patients who have failed androgen deprivation therapy (ADT) and have not received chemotherapyMetastatic Castration-Resistant Prostate Cancer (mCRPC)Adult patients; (2) for the treatment of those with a high risk of metastasisNon-metastatic Castration-Resistant Prostate Cancer (nmCRPC)Adult patients. (Bioon.com)
Original Source: Astellas' XTANDI (enzalutamide)approved by European Commission for Men with Metastatic Hormone-Sensitive Prostate Cancer