March 28, 2021/
BioonBIOON/-- Japanese pharmaceutical company Astellas recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of a new indication for Xtandi® (brand name: Anketang; 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 the urgent need for new treatment options.
Now, the CHMP opinion will be submitted to the European Commission (EC) for review, which typically makes a final decision within two months. If approved, Xtandi will be the only oral treatment regimen approved by the EC for three different types of advanced prostate cancer: non-metastatic and metastatic castration-resistant prostate cancer (CRPC), and mHSPC.
The CHMP’s positive opinion is based on data from the pivotal Phase 3 ARCHS trial (NCT02677896). This trial 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 group demonstrated a significant 61% reduction in the risk of radiographic progression or death (HR=0.39 [95% CI: 0.30-0.50]; p<0.0001). In this trial, the safety profile of Xtandi was consistent with previous CRPC
Clinical TrialsThe 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 treated with Xtandi + ADT and those treated with placebo + ADT (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 excess 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 that lower testosterone levels, the disease is considered hormone-sensitive (or castration-sensitive). For male patients with metastatic hormone-sensitive prostate cancer (mHSPC) who initiate androgen deprivation therapy (ADT), the median survival time is approximately 3–4 years.
Xtandi® (enzalutamide) is an androgen receptor signaling inhibitor administered orally once daily. This drug 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—where AR translocation to the nucleus is an essential step in AR-mediated gene regulation; and (3) impairment of DNA binding—where AR binding to DNA is critical for regulating gene expression.
Xtandi, launched in 2012, is a blockbuster product in the field of prostate cancer treatment. The drug 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 (ANCTAN®, enzalutamide) was approved in November 2019 and November 2020, respectively: (1) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic and have not received chemotherapy after failure of androgen deprivation therapy (ADT); (2) for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis. (Bioon.com)
Original Source: Astellas Receives Positive CHMP Opinion for XTANDI™ (enzalutamide) for Patients with Metastatic Hormone-Sensitive Prostate Cancer
