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FDA expands Kisqali approval for advanced, metastatic breast cancer
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The FDA approved ribociclib for use in combination with an aromatase inhibitor as initial endocrine-based therapy for pre- or perimenopausal women with hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer.
The FDA also approved ribociclib (Kisqali, Novartis) in combination with fulvestrant (Faslodex, AstraZeneca) for the treatment of postmenopausal women with hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.
Ribociclib in combination with an aromatase inhibitor was previously approved as an initial endocrine therapy for the treatment of postmenopausal women with hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer.
The FDA based the expanded approval for ribociclib plus an aromatase inhibitor for the treatment of pre- or perimenopausal woman on results from the randomized, double-blind MONALEESA-7 trial. Researchers randomly assigned pre- or perimenopausal women to ribociclib plus a nonsteroidal aromatase inhibitor or tamoxifen and goserelin (Zoladex; TerSera, AstraZeneca) or placebo plus a nonsteroidal aromatase inhibitor or tamoxifen and goserelin. Among 495 patients who received a nonsteroidal aromatase inhibitor, results showed a median PFS of 27.5 months among patients randomly assigned ribociclib compared with 13.8 months among those assigned placebo (HR = 0.56; 95% CI, 0.43-0.74).
The FDA based the approval of ribociclib plus fulvestrant for postmenopausal women with breast cancer on results from the MONALEESA-3 trial. This randomized double-blind, placebo-controlled trial included 726 postmenopausal women with hormone receptor-positive, HER-2-negative, advanced breast cancer who received no or only one line of prior endocrine treatment. Median PFS was 20.5 months among patients randomly assigned ribociclib compared with 12.8 months among controls (HR = 0.59; 95% CI, 0.48-0.73).
“The approval adds a new treatment choice for patients with breast cancer,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “We are committed to continuing to bring more treatment options to patients.”
The most common treatment-related adverse reactions included neutropenia, nausea, infections, fatigue, diarrhea, leukopenia, vomiting, alopecia, headache, constipation, rash and cough.
These are the first approvals under two new FDA pilot programs — Real-Time Oncology Review and Assessment Aid — aimed to make the development and review of cancer drugs more efficient.
“With this approval, we’ve demonstrated some of the benefits of the new programs that we’re piloting for our review of cancer drugs, to improve regulatory efficiency while enhancing the process for evaluating the data submitted to us,” FDA Commissioner Scott Gottlieb, MD, said in a press release.
“With today’s approval, the FDA used these new approaches to allow the review team to start analyzing data before the actual submission of the application and help guide the sponsor’s analysis of the top-line data to tease out the most relevant information,” he added. “This enabled our approval less than one month after the June 28 submission date and several months ahead of the goal date.”