麻豆传媒

The FDA on Thursday for the frontline treatment of late-stage, hormone receptor (HR)-positive, HER2-negative breast cancer.

Ribociclib -- a cyclin-dependent kinase (CDK) 4/6 inhibitor -- is now approved in combination with an aromatase inhibitor (AI) for treating pre- or postmenopausal women as upfront therapy, and in combination with fulvestrant for the treatment of postmenopausal women as upfront therapy or following progression on an endocrine therapy.

"The approval adds a new treatment choice for patients with breast cancer," Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence, said in the agency's announcement. "We are committed to continuing to bring more treatment options to patients."

This is the first approval to be a part of two new FDA pilot programs, Real-Time Oncology Review and Assessment Aid. The programs aim to improve the efficiency and rigor of the approval process by having researchers submit study results on the safety and effectiveness of the product earlier, so the agency can review the data before it is officially submitted and troubleshoot any missing information, which often causes delays. Applicants will also now use a new structured template when officially submitting data, so the FDA can streamline its analysis approach.

"These new processes are good for patients, good for healthcare 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," FDA Commissioner Scott Gottlieb, MD, said in the statement. "We can improve efficiency and solidify our gold standard for review."

The expanded indications were based on a pair of phase III trials. In MONALEESA-7, premenopausal women who received ribociclib plus an AI had a higher median progression-free survival (PFS) than those that received an AI and placebo (27.5 versus 13.8 months).

In , postmenopausal women assigned to ribociclib plus fulvestrant reported a higher PFS than a control group that received fulvestrant and placebo (20.5 versus 12.8 months).

Ribociclib was in combination with an AI to treat HR-positive, HER2-negative breast cancer in postmenopausal women with advanced cancer. Common adverse events associated with the the CDK 4/6 inhibitor include infections, leukopenia, neutropenia, headache, vomiting, and alopecia, among others.

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