In a notable development in the field of oncology, the US Food and Drug Administration (FDA) has approved AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer. This approval is especially significant for patients with specific biomarker alterations (PIK3CA, AKT1, or PTEN), who have previously progressed on endocrine-based regimens.

Clinical Trial Success and Drug Profile

This approval stems from the successful outcomes of the CAPItello-291 Phase III trial. Published in The New England Journal of Medicine, the trial showed that Truqap, in combination with Faslodex, reduced the risk of disease progression or death by 50% compared to Faslodex alone. Truqap, a first-in-class ATP-competitive inhibitor of AKT isoforms, demonstrates a new approach to treating this cancer subtype.

Breast Cancer Landscape and the Need for Advanced Treatments

Breast cancer remains the most common cancer worldwide. HR-positive breast cancer, the most prevalent subtype, often develops resistance to first-line therapies, highlighting the urgency for innovative treatment options. Truqap, administered in a four days on, three days off schedule, addresses this critical need.

Expert Opinions and AstraZeneca’s Commitment

Komal Jhaveri, MD, from Memorial Sloan Kettering Cancer Center, emphasized the importance of this combination therapy in extending the effectiveness of endocrine therapies. Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, underlined the critical role of the PI3K/AKT pathway in HR-positive breast cancer and Truqap’s significance as a first-in-class medicine.

Companion Diagnostic Test and Global Regulatory Review

Concurrent with this approval, the FDA also sanctioned a companion diagnostic test for detecting relevant biomarker alterations. Truqap, along with Faslodex, is currently under review by various international regulatory authorities as part of Project Orbis.

Financial Implications and Future Prospects

Following this US approval, Astex Therapeutics is poised to receive milestone payments and royalties from AstraZeneca. Truqap’s ongoing clinical research program focuses on tumors reliant on the PI3K/AKT pathway, exploring its efficacy in various tumor types and in combination with other treatments.

Faslodex’s Role in Breast Cancer Treatment

Faslodex, an endocrine therapy, is also a crucial component of this treatment combination, having previously been approved for various stages and combinations in breast cancer therapy.

In summary, the FDA’s approval of Truqap in combination with Faslodex marks a pivotal moment in the treatment of HR-positive, HER2-negative advanced breast cancer, offering hope to many patients facing this challenging diagnosis.

  AstraZeneca, Breast Cancer, Capivasertib, Faslodex, Komal Jhaveri, Oncology, Truqap, US FDA, US Food and Drug Administration, USA