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CHMP Recommends AstraZeneca's Truqap With Faslodex for Certain Breast Cancer Patients

NEW YORK – AstraZeneca on Monday said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended its AKT inhibitor Truqap (capivasertib) with Faslodex (fulvestrant) as a treatment for patients who have estrogen receptor-positive, HER2-negative, locally advanced or metastatic breast cancer with one or more alterations in PIK3CA, AKT1, or PTEN and have progressed on an endocrine-based regimen.

CHMP recommended the European Commission approve the regimen after reviewing results from the Phase III CAPItello-291 trial in which Truqap-Faslodex reduced the risk of disease progression or death by 50 percent compared with Faslodex alone. The median progression-free survival was 7.3 months in the Truqap group versus 3.1 months in the control group.

Alterations in PIK3CA, AKT1, and PTEN occur in about 50 percent of patients with advanced hormone receptor-positive breast cancer. These patients typically develop resistance to standard first-line treatment with endocrine therapies and CDK4/6 inhibitors. AstraZeneca believes the Truqap-Faslodex combination can make endocrine-based therapies more beneficial for patients.

"Today's news reinforces the practice-changing potential of Truqap in combination with Faslodex to extend the effectiveness of endocrine-based treatment approaches for patients who experience tumor progression on, or resistance to, widely used endocrine-based therapies," Susan Galbraith, AstraZeneca executive VP of oncology R&D, said in a statement. "This recommendation recognizes the high unmet need in this biomarker-specific patient population."

Truqap-Faslodex is already approved in the US, Japan, and several other countries in this setting, and regulatory applications are under review in China and elsewhere. In March, the US Food and Drug Administration approved Roche subsidiary Foundation Medicine's FoundationOne CDx as a companion diagnostic to identify breast cancer patients who have alterations in PIK3CA, AKT1, and PTEN and are likely to benefit from the combo.