In a landmark decision that heralds a new era in the treatment of advanced hormone receptor-positive breast cancer in Japan, the combination of Truqap (capivasertib) and Faslodex (fulvestrant) has received approval for patients with specific genetic mutations. This innovative treatment strategy, which targets patients with alterations in the PIK3CA, AKT1, or PTEN genes, marks the introduction of the first and only AKT inhibitor in Japan for this patient population, promising enhanced therapeutic outcomes.
The green light from the Japanese Ministry of Health, Labour, and Welfare (MHLW) comes in the wake of compelling results from the CAPItello-291 Phase III trial. This study demonstrated that Truqap, in combination with Faslodex, significantly reduced the risk of disease progression or death by 50% compared to Faslodex alone among patients with the aforementioned biomarker alterations. This significant milestone in breast cancer therapy is underpinned by data showcasing a median progression-free survival leap from 3.1 to 7.3 months in the targeted patient group.
In Japan, breast cancer remains a leading cause of morbidity and mortality among women, with over 90,000 new diagnoses and more than 17,000 deaths in 2022 alone. Given that the majority of breast cancer tumors are hormone receptor-positive yet HER2-negative, this approval addresses a critical need for novel treatment avenues that can effectively manage and contain this prevalent cancer subtype.
Truqap’s Approval Marks a New Era for Targeted Breast Cancer Therapy in Japan
Masakazu Toi, MD, Ph.D., at Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, emphasizes the significance of this approval, highlighting it as a pivotal advancement for approximately half of the patients in Japan facing advanced stages of this cancer type with specific genetic mutations. The ability to identify these biomarker alterations in patients enables healthcare providers to tailor treatments more effectively, prolonging the efficacy of endocrine-based therapies and delaying disease progression.
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, reflects on the approval as a critical development for Japanese women battling breast cancer. By offering a novel treatment option targeting specific mutations, Truqap represents a significant step forward in the quest for more effective and personalized breast cancer therapies.
The approval also includes the green light for a companion diagnostic test, ensuring that patients eligible for this treatment can be accurately identified and treated. This strategic decision by the MHLW not only enhances the precision of breast cancer therapy in Japan but also sets a precedent for other nations evaluating similar treatments.
AstraZeneca’s Global Quest: Pioneering Personalized Cancer Care with Targeted Therapies
As AstraZeneca continues to seek approvals in China, the European Union, and other regions, this breakthrough serves as a beacon of hope for countless patients globally. It underscores the potential of targeted therapies in transforming the landscape of cancer care, moving towards more personalized, effective treatment modalities.
This pivotal approval signifies more than just a new treatment option; it represents a shift towards personalized medicine in the battle against breast cancer, acknowledging the complexity of the disease and the necessity for tailored therapeutic approaches. As AstraZeneca and the global medical community continue to explore and develop treatments based on genetic markers, patients worldwide stand to benefit from more effective, individualized care strategies.
Resource: AstraZeneca, March 27, 2024
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