darolutamide Gains Expanded Approval in South Korea, Intensifying prostate cancer Treatment Competition
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- darolutamide Gains Expanded Approval in South Korea, Intensifying prostate cancer Treatment Competition
Seoul, South Korea - August 20, 2025 – Competition is escalating among pharmaceutical companies vying for dominance in the prostate cancer treatment market, fueled by a rising incidence of the disease. Recent attention has focused on Darolutamide, marketed as New Becca, following its expanded approval for use in South Korea.
New Becca Approved for Wider Use in Metastatic Hormone-Sensitive Prostate Cancer
Professor Hyun-ho Han of the Department of Urology at Sinchon Severance hospital attended a Bayer Korea event on August 20th to assess the clinical implications of the expanded indication for New Becca, an oral androgen receptor inhibitor (ARI). New becca is now approved for use in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (MHSPC). The approval from the Ministry of Food and Drug Safety was based on data from the pivotal Phase 3 ARANOTE trial.
The ARANOTE trial, involving 669 patients with MHSPC, demonstrated that the combination of new Becca and ADT substantially reduced the risk of radiographic progression or death compared to placebo (HR 0.54; 95% CI 0.41-0.71; p <0.0001).
Did You Know? Prostate cancer is the most common cancer in men worldwide, with an estimated 1.4 million new cases diagnosed in 2020.
This benefit was consistent across patient subgroups, including those with high- and low-volume disease.
Survival Benefits and Quality of Life Improvements
Further analysis of overall survival data indicated a potential survival benefit with New Becca plus ADT (HR = 0.81, 95% CI 0.59-1.1) compared to placebo. The combination also demonstrated notable delays in PSA levels, worsening quality of life, and pain progression, suggesting a meaningful enhancement in patient well-being. Adverse events were generally mild, primarily grade 1 or 2, with no significant differences between treatment groups.
Tailoring Treatment to Individual Patient Needs
Professor Han emphasized the importance of personalized treatment approaches, noting that many Korean MHSPC patients are elderly and have comorbidities. “Custom treatment for the patient’s characteristics is absolutely possible,” he stated.He suggested that patients requiring aggressive initial treatment could benefit from a New Becca, ADT, and taxane triple combination, while those less suited for intensive treatment-due to age, chronic conditions, or fall risk-might be better served by a New Becca and ADT dual combination.
New Becca’s unique molecular structure, characterized by low blood-brain barrier (BBB) transmittance and minimal drug-drug interactions (DDI), makes it particularly well-suited for older prostate cancer patients who are more susceptible to central nervous system-related side effects.
Pro Tip: Early detection is crucial for successful prostate cancer treatment. Regular check-ups and screenings are highly recommended.
Competitive Landscape and Market Outlook
With its expanded approval, New Becca is poised to compete with established therapies such as Extandi (enzalutamide, Korea astellas), Zytiga (abiraterone acetate, Korea Janssen), and Erleada (apalutamide, Korea Janssen) in the Korean market. Health insurance coverage for ADT combinations, already available for Erleada as April 2023 and Extandi since November 2023, will be a key factor in determining market share.
| Drug Name | Manufacturer | Initial Approval (Korea) | Current Indication |
|---|---|---|---|
| New Becca (Darolutamide) | Bayer Korea | Recent Expansion | MHSPC (in combination with ADT) |
| Extandi (Enzalutamide) | Korea Astellas | 2014 (MCRPC) | MCRPC, MHSPC (with ADT) |
| Zytiga (Abiraterone Acetate) | Korea Janssen | 2012 | MCRPC |
| Erleada (Apalutamide) | Korea Janssen | N/A | MHSPC (with ADT) |
Professor Han noted that while apalutamide is effective, managing its associated skin rash side effects is essential. Securing health insurance coverage for New Becca is therefore a top priority for Bayer Korea.Roh Myung-kyu, Portfolio Lead at Bayer Korea, acknowledged the sensitivity of reimbursement discussions with government officials.
The development of these therapies reflects a growing understanding of prostate cancer biology and a commitment to improving patient outcomes. As treatment options expand, clinicians have more tools to tailor care to the individual needs of each patient. the androgen receptor pathway is a key target in prostate cancer treatment, as androgens fuel the growth of many prostate cancers [[1]]. Newer agents like Darolutamide offer improved specificity and reduced side effects compared to earlier generations of androgen deprivation therapies [[2]].
What are your thoughts on the increasing competition in prostate cancer treatment? How do you see these advancements impacting patient care in the coming years?
Prostate Cancer: A Growing Global Health Concern
Prostate cancer remains a significant public health challenge worldwide.Incidence rates vary geographically, with higher rates observed in North America, Europe, and the Caribbean. Early detection through prostate-specific antigen (PSA) testing and digital rectal exams (DRE) is crucial for improving treatment outcomes. Lifestyle factors, such as diet and exercise, may also play a role in prostate cancer risk.
Frequently Asked Questions About Prostate Cancer and New Treatments
- What is prostate cancer? Prostate cancer is a disease in which malignant cells form in the tissues of the prostate gland.
- What are the symptoms of prostate cancer? Early prostate cancer often has no symptoms. Later symptoms can include difficulty urinating, blood in urine or semen, and bone pain.
- What is New Becca (Darolutamide)? New Becca is an oral medication used to treat metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy.
- How does Darolutamide work? Darolutamide blocks the effects of androgens, hormones that can fuel the growth of prostate cancer cells.
- Is New becca covered by insurance? Insurance coverage varies by region and plan. Bayer Korea is actively pursuing reimbursement approval.
- What are the potential side effects of Darolutamide? Common side effects include fatigue, pain, and decreased appetite.
Disclaimer: This article provides general data and should not be considered medical advice.Please consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.
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