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Project Orbis News | Updates | Truqap approved in the US

November 17, 2023

FDA Approves Truqap Plus Fulvestrant Combination for Advanced HR-Positive Breast Cancer


AstraZeneca has announced that the U.S. Food and Drug Administration (FDA) has given the green light for the use of AstraZeneca's Truqap (capivasertib) and fulvestrant combination in the treatment of advanced hormone receptor (HR)-positive, HER2-negative breast cancer.


This regulatory approval is designed for adults with identified biomarker alterations such as PIK3CA, AKT1, or PTEN. Eligibility includes individuals who have experienced disease progression with at least one previous endocrine-based treatment in the metastatic setting or those facing recurrence within 12 months after completing adjuvant therapy.


The approval follows the promising outcomes of the CAPItello-291 Phase III trial, disclosed earlier this year in The New England Journal of Medicine. The trial demonstrated a substantial 50% reduction in the risk of disease progression or death when Truqap was administered alongside fulvestrant, compared to fulvestrant alone. This efficacy was particularly noticeable in patients with tumors displaying PI3K/AKT/PTEN pathway biomarker alterations, with a hazard ratio of 0.50 and a median progression-free survival (PFS) of 7.3 months in the Truqap arm versus 3.1 months in patients on fulvestrant monotherapy.


Globally, breast cancer poses a significant public health challenge, with the HR-positive subtype constituting over 65% of cases. Biomarker alterations in PIK3CA and AKT1, in conjunction with PTEN variations, collectively impact up to half of patients grappling with advanced HR-positive breast cancer. Despite the widespread use of endocrine therapies, the emergence of resistance underscores the urgent need for innovative treatment options like Truqap.


The safety profile of the Truqap plus fulvestrant combination, as indicated by the CAPItello-291 trial, aligns with observations from previous trials evaluating this regimen.


This FDA approval is part of Project Orbis, an initiative streamlining the submission and review of oncology medicines among international partners. Regulatory scrutiny is extending to various countries, including Australia, Brazil, Canada, Israel, Singapore, Switzerland, and the UK. Simultaneously, regulatory assessments for this combination therapy are in progress in China, the European Union, Japan, and numerous other nations, promising a more extensive global impact in the battle against advanced HR-positive breast cancer.

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