Lilly’s abemaciclib to receive priority review for breast cancer in US

Lilly has announced that its breast cancer drug abemaciclib has been handed priority review status by the US Food and Drug Administration (FDA).

The regulator has accepted the new drug application for abemaciclib and will now assess the drug in two indications, the first being as a monotherapy for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease.

Abemaciclib will also be assessed in combination with fulvestrant in women with HR-positive, HER2-negative advanced breast cancer who had disease progression following endocrine therapy.

This submission is based on positive findings from the MONARCH 1 and MONARCH 2 studies, which have demonstrated the safety and efficacy of the drug in these indications.

Lilly intends to submit abemaciclib to European regulators in the third quarter of 2017 and to Japanese regulators before the end of the year.

Dr Levi Garraway, senior vice-president for global development and medical affairs at Lilly Oncology, said: "Breast cancer is a complex disease, and the need still exists for new treatment options as patients face a significant disease burden."

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