Novartis' Kisqali garners FDA approval as first-line breast cancer treatment

The FDA approved Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor positive, HER2-negative advanced or metastatic breast cancer, the company announced. The oral CDK4/6 inhibitor, formerly known as LEE011, was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Otsuka's Astex Pharmaceuticals subsidiary.

According to Novartis, the approval of Kisqali was based on data from the Phase III MONALEESA-2 trial. Results from an interim analysis of the study demonstrated that Kisqali plus the company's Femara (letrozole) reduced the risk of progression or death by 44 percent versus Femara alone. The drugmaker added that at a later analysis with additional 11-month follow-up, a median progression-free survival of 25.3 months was observed for Kisqali plus Femara, compared to 16 months for Femara alone.

"This is a significant result for women with this serious form of breast cancer," remarked principal study investigator Gabriel N. Hortobagyi, adding "these results affirm that combination therapy with a CDK4/6 inhibitor like [Kisqali] and an aromatase inhibitor should be a new standard of care for initial treatment of HR+ advanced breast cancer." Novartis' application for Kisqali was granted priority review by the FDA in November last year.

Novartis indicated that a four-week supply of Kisqali will have a list price of $10 950 for the highest dose of 600mg, while the 400mg dose will cost $8760 and the 200mg dose will be priced at $4380. For further analysis, read ViewPoints: Novartis decides to play the price game with newly approved Kisqali.

In 2015, Pfizer's Ibrance (palbociclib) became the first CDK4/6 approved by the FDA, in combination with Femara, for the treatment of postmenopausal women with oestrogen receptor-positive, HER2-negative metastatic breast cancer.