Novartis' Kisqali gains expanded FDA approval in breast cancer, less than one month after filing

Novartis said Wednesday that the FDA expanded approval of Kisqali (ribociclib) to include two new uses in women with hormone-receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer. The company noted that the agency approved its new application for the CDK4/6 inhibitor in less than one month after submission, reviewing it under its Real-Time Oncology Review and Assessment Aid pilot programmes. 

Specifically, Kisqali gained FDA approval in combination with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. The regulator also authorised Kisqali in combination with AstraZeneca's Faslodex (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. 

Novartis Oncology CEO Liz Barrett said "compelling data for Kisqali have led to the broadest first-line indications of any CDK4/6 inhibitor," adding that "with this new approval Kisqali has the potential to help even more people in the US live a longer life without progression of disease from this incurable form of breast cancer." 

Expanded approval of the drug was supported by safety and efficacy data from the late-stage MONALEESA-3 and MONALEESA-7 studies. Results from MONALEESA-7 unveiled last November showed that Kisqali in combination with oral hormonal therapies and goserelin significantly prolonged progression-free survival versus endocrine treatment alone in pre- and perimenopausal women with HR-positive, HER2-negative advanced breast cancer. 

FirstWord reports in this therapy area - KOL Insight Breast Cancer: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more. 

"With this approval, we've demonstrated some of the benefits of the new programmes 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," remarked FDA Commissioner Scott Gottlieb. "By analysing data earlier in the process, before formal submission to the FDA, and evaluating submissions in a structured template, we can make it easier to identify earlier when applications are missing key analysis or information that can delay reviews," he explained. 

Kisqali was first approved in the US last year for use with an aromatase inhibitor as initial endocrine-based therapy to treat HR-positive, HER2-negative breast cancer in postmenopausal women whose cancer is advanced or has spread to other parts of the body. The drug was granted breakthrough therapy status in January for the first-line treatment of pre- or perimenopausal women with the disease.


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