Breast Cancer Novartis Food And Drug Administration Ribociclib Kisqali Oncology Aromatase Inhibitor Her2

Ribociclib Gains New FDA Breast Cancer Approval

Novartis' Kisqali receives accelerated approval for early-stage breast cancer

New indication gives patients access to precision therapy earlier in treatment

The Food and Drug Administration (FDA) has granted accelerated approval to Novartis' Kisqali (ribociclib) for the adjuvant treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early-stage breast cancer at high risk of recurrence.

The approval is based on results from the Phase III monarchE trial, which showed that Kisqali significantly reduced the risk of invasive disease-free survival (iDFS) by 28% compared to placebo in patients with high-risk, HR+/HER2-, node-positive, early-stage breast cancer who had received prior neoadjuvant chemotherapy.

The addition of Kisqali to standard adjuvant endocrine therapy resulted in a 2.7-year iDFS, compared to 2.0 years with placebo.

"This accelerated approval is an important step forward for patients with high-risk, early-stage breast cancer," said Dr. Shanu Modi, Novartis Oncology's Global Head of Development.

"Kisqali is now approved for use in both the early and advanced stages of HR+/HER2- breast cancer, providing patients with a precision therapy option throughout their treatment journey."

Kisqali is an oral, once-daily cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor that selectively inhibits the cell cycle progression of cancer cells. It is currently approved in combination with an aromatase inhibitor for the treatment of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer and for the adjuvant treatment of patients with HR+, HER2-, node-positive, early-stage breast cancer at high risk of recurrence.

The FDA's accelerated approval program allows for the approval of drugs for serious conditions based on promising early clinical data. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.