FDA Grants First Approval Through New Oncology Review Pilot Programs

The U.S. Food and Drug Administration (FDA) approved ribociclib in combination with an aromatase inhibitor for pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy. Ribociclib was also approved in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer as initial endocrine based therapy or following disease progression on endocrine therapy.

This is the first approval to occur through two new FDA pilot programs that seek to make the development and review of oncology agents more efficient. One of the programs, Real-Time Oncology Review, allows the FDA to review a bulk of the data before the information is formally submitted. Thus, upon review, the agency is familiar with the data. 

The second program, Assessment Aid, allows the applicant to organize its submission into a structured format, which provides a more streamlined approach to reviewing data and illustrating the FDA’s analysis. It allows drug reviewers to focus on the key benefit-risk and labeling issues rather than administrative issues, according to the FDA. 

Source: FDA