Novartis’ new breast cancer drug accepted for regulatory review in US and EU

Novartis has announced that its new breast cancer drug LEE011, also known as ribociclib, has been accepted for regulatory review.

The European Medicines Agency has accepted the company's marketing authorisation application to assess LEE011 as a first-line treatment for postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer, in combination with letrozole.

Additionally, the US Food and Drug Administration has accepted a new drug application for the therapy in the same indication, and has granted priority review status to the treatment based on the strong progression-free survival benefits it has demonstrated in clinical trials.

Priority review designation means the drug will be reviewed within six months, compared to ten months under standard review. This status is provided to candidates that can offer significant benefits in treating serious conditions for which there is currently no cure.

Bruno Strigini, chief executive officer of Novartis Oncology, said the company will be "working diligently with … health authorities to bring this treatment to patients around the world as fast as possible".

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