July 18, 2018
The US Food and Drug Administration (FDA) approved two new indications for a breast cancer drug used in combination with an aromatase inhibitor or with fulvestrant, respectively, for the treatment of patients with breast cancer.
Ribociclib (Kisqali; Novartis) is now approved in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer. The drug has also been approved for use 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 after disease has progressed with endocrine therapy.
The FDA’s approval of the first indication is based on results from a clinical trial of 495 patients who received ribociclib and an aromatase inhibitor or placebo and an aromatase inhibitor. The median progression-free survival (PFS) was longer for patients who received ribociclib plus an aromatase inhibitor (27.5 months vs 13.8 months with placebo).
The second indication was approved based on results demonstrated in a clinical trial of 726 patients who received ribociclib and fulvestrant or placebo and fulvestrant. The median PFS was longer for patients who received ribociclib plus fulvestrant (20.5 months vs 12.8 months with placebo).
This approval is the first to come out of two new FDA pilot programs that aim to streamline the process for developing and reviewing cancer drugs while improving the agency’s rigorous standard for efficacy and safety evaluation. These programs allow the FDA to start evaluating clinical data as results from trials become available.
The first program, Real-Time Oncology Review, allows the FDA to review data early and before the information is formally submitted to the FDA. The second program, Assessment Aid, is a template that applicants can use to organize their submission into a structured format, which in turn facilitates the FDA’s review of the application.
The two programs are currently being used for supplemental applications being submitted for FDA-approved cancer drugs, and could later be expanded for use with original drugs and biologics.
“These new processes are good for patients, good for health care providers, good for product developers, and good for the FDA, by allowing our staff to have more time to engage with product developers and focus on the key aspects of drug reviews. We can improve efficiency and solidify our gold standard for review,” said FDA Commissioner Scott Gottlieb, MD, in a press release (June 18, 2018).
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