FDA Hails Novartis' Kisqali a Breakthrough

Little more than 10 months after its approval to treat some postmenopausal breast cancer patients, Novartis’ Kisqali (ribociclib) snagged Breakthrough Therapy Designation to treat a new segment of premenopausal breast cancer patients.

This morning, the Swiss-based Novartis said the U.S. Food and Drug Administration awarded the new designation for initial endocrine-based treatment of premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor. The company said the Breakthrough Therapy Designation is based on positive results from the Phase III MONALEESA-7 trial. Results from that study showed Kisqali in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy significantly prolonged progression-free survival (PFS) compared to endocrine therapy alone. Novartis said the Kisqali combination therapy provided 22.1 months median PFS compared to 11 months for tamoxifen and goserelin alone. Additionally, Kisqali in combination with an aromatase inhibitor and goserelin demonstrated 27.5 months median PFS compared to 13.8 months for an aromatase inhibitor and goserelin alone, the company said.

Samit Hirawat, head of global oncology drug development at Novartis, said the FDA’s designation reflects the “significance and promise” of the MONALEESA-7 data presented at the San Antonio Breast Cancer Symposium last month.

“Younger women often have distinct treatment goals and needs, and it is important for oncologists to offer effective and well-studied treatment options for their specific disease. We look forward to working with FDA to make this combination therapy available to premenopausal women living with HR+/HER2- advanced breast cancer in the U.S. as soon as possible,” Hirawat said in a statement.

Premenopausal breast cancer is a biologically distinct and more aggressive disease than postmenopausal breast cancer. Novartis noted that premenopausal breast cancer is the leading cause of cancer death in women 20-59 years old.

Kisqali is a selective cyclin-dependent kinase inhibitor. Kisqali works by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). If the proteins become over-activated, they can fuel cancer cells and cause them to grow and divide too quickly. Kisqali was first approved by the FDA in March 2017 as a first-line treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

The MONALEESA-7 trial was the first Phase III trial entirely dedicated to evaluating a CDK4/6 inhibitor in premenopausal women with HR+/HER2- advanced breast cancer. Novartis said that no new safety concerns were seen during the trial and that adverse events were similar to the MONALEESA-2 trial that was used to secure the March 2017 approval of Kisqali.