publication date: Oct. 13, 2017

Drugs and Targets

FDA grants priority review for Lilly’s Verzenio (abemaciclib) for advanced breast cancer

Eli Lilly and Co. said FDA has granted Priority Review designation for its New Drug Application for Verzenio (abemaciclib), a cyclin-dependent kinase (CDK) 4 & 6 inhibitor.

The NDA was based upon the positive interim results from MONARCH 3, a study of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

The results were presented at the European Society for Medical Oncology 2017 Congress, and recently published in the Journal of Clinical Oncology

Priority Review aims to expedite the review of applications for drugs that, if approved, would represent a significant advance in treatment. With Priority Review of a new drug, the FDA’s goal is to take action within eight months of receiving an application, compared with the standard review timeframe of 12 months.


Boehringer Ingelheim’s Gilotrif granted Priority Review

Boehringer Ingelheim said the supplemental New Drug Application for Gilotrif (afatinib) has been accepted for filing and granted Priority Review by FDA. The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 21 (L861Q), G719X, or S768I substitution mutations as detected by an FDA-approved test.

Gilotrif is approved in the U.S., EU (Giotrif), and many other markets for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, and squamous cell carcinoma of the lung whose disease has … Continue reading FDA grants priority review for Lilly’s Verzenio (abemaciclib) for advanced breast cancer

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