Novartis receives EU approval for breast cancer therapy Kisqali

Novartis has announced that its cancer therapy Kisqali has been approved as a treatment for advanced breast cancer in Europe.

The European Commission has ratified Kisqali in combination with an aromatase inhibitor for the treatment of postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer as an initial endocrine-based therapy.

It is the first CDK4/6 inhibitor approved in Europe based on data from a first-line phase III trial, which met its primary endpoint by demonstrating progression-free survival benefits following an interim analysis.

The opinion included a recommendation that allows oncologists to prescribe Kisqali with any aromatase inhibitor, including letrozole, anastrozole or exemestane, that is deemed to be most appropriate for a given patient.

Bruno Strigini, chief executive officer of Novartis Oncology, said: "We are proud of our collaboration with study investigators and patients, which provides the medical community with an important new treatment option for women with advanced or metastatic breast cancer."

Up to one-third of patients with early-stage breast cancer will subsequently develop advanced disease, for which there is currently no cure, meaning there is strong demand for new therapies.

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