CHMP Recommends Approval of Truqap and Faslodex in the EU for Advanced ER-Positive Breast Cancer Patients

AstraZeneca’s Truqap (capivasertib) combined with Faslodex (fulvestrant) has received a positive recommendation for approval in the European Union (EU) for treating adult patients with locally advanced or metastatic breast cancer that is estrogen receptor (ER)-positive and HER2-negative. This recommendation comes from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which based its decision on data from the CAPItello-291 Phase III trial published in The New England Journal of Medicine.

In the trial, the combination of Truqap and Faslodex reduced the risk of disease progression or death by 50% compared to Faslodex alone in patients with tumors harboring PI3K, AKT, or PTEN alterations. These alterations are present in approximately 50% of patients with advanced HR-positive breast cancer.

Breast cancer remains a significant cause of cancer-related deaths in Europe, with over 140,000 deaths and more than 550,000 new cases diagnosed annually. HR-positive breast cancer, which accounts for 70% of breast cancer cases, often progresses due to estrogen receptors, making endocrine therapies targeting ER-driven disease the primary treatment option. However, resistance to these therapies frequently develops, necessitating alternative approaches to extend their effectiveness.

Dr. Mafalda Oliveira from Vall d’Hebron University Hospital in Barcelona highlighted the urgent need for more effective therapies for advanced ER-positive breast cancer patients, particularly those with specific tumor biomarkers. She noted the significant reduction in disease progression or death seen with the Truqap-Faslodex combination in patients with PIK3CA, AKT1, or PTEN alterations, as demonstrated in the CAPItello-291 trial.

Susan Galbraith, from AstraZeneca, emphasized the potential of Truqap in combination with Faslodex to address the unmet needs of patients who experience disease progression on or resistance to standard endocrine-based therapies.

The safety profile of Truqap plus Faslodex was consistent with previous trials evaluating this combination. Regulatory applications for this combination therapy are also under review in other countries, including China. Similar indications for Truqap combined with Faslodex are already approved in Japan, the US, and several other countries based on data from the CAPItello-291 trial.

The CAPItello-291 trial, a Phase III study, evaluated the efficacy of Truqap in combination with Faslodex versus placebo plus Faslodex in patients with locally advanced or metastatic HR-positive, HER2-low or negative breast cancer. The trial included patients whose disease had recurred or progressed after prior treatment with aromatase inhibitors and, in many cases, CDK4/6 inhibitors.

Truqap is a first-in-class AKT inhibitor approved in several countries for HR-positive, HER2-negative locally advanced or metastatic breast cancer with specific biomarker alterations following recurrence or progression on an endocrine-based regimen. It is currently being investigated in Phase III trials for various breast cancer subtypes and other tumor types.

Faslodex is an endocrine therapy used for the treatment of estrogen receptor-positive, locally advanced, or metastatic breast cancer. It is also approved in combination with CDK4/6 inhibitors for certain patient populations.

AstraZeneca is committed to advancing breast cancer treatment through a comprehensive portfolio of approved and investigational therapies. The company aims to redefine the clinical paradigm for breast cancer treatment and ultimately eliminate breast cancer as a cause of death.

In oncology, AstraZeneca is focused on delivering life-changing medicines to patients by understanding the complexities of cancer biology and developing innovative treatments. The company’s diverse portfolio and pipeline aim to address some of the most challenging cancers and transform the patient experience.

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