Novartis breast cancer therapy Kisqali granted US breakthrough therapy designation

Novartis has announced that its breast cancer therapy Kisqali has been designated as a breakthrough therapy by the US Food and Drug Administration (FDA).

The regulator has granted this designation to acknowledge the promise Kisqali offers in the initial endocrine-based treatment of pre- or perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, in combination with tamoxifen or an aromatase inhibitor.

This status was supported by data from the phase III MONALEESA-7 study, which showed that Kisqali offered superior efficacy when used in combination with oral endocrine therapy, compared to oral endocrine therapy alone.

Breakthrough therapy designation is designed to expedite the development and review of potential new medicines that treat serious or life-threatening conditions, provided that they have demonstrated substantial improvement benefits over available therapies.

Dr Samit Hirawat, head of global drug development at Novartis Oncology, said: "Younger women often have distinct treatment goals and needs, and it is important for oncologists to offer effective and well-studied treatment options for their specific disease."

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