- Novartis on Monday secured U.S. approval for its closely watched CDK 4/6 inhibitor in certain advanced breast cancer types, giving the Swiss pharma a competitor to Pfizer’s fast growing Ibrance (palbociclib).
- The Food and Drug Administration approved Kisqali (ribociclib), in combination with an aromatase inhibitor, for first-line treatment of postmenopausal women with HR+, HER2- metastatic breast cancer.
- By securing approval, Novartis heads off Eli Lilly, which has been moving its own CDK 4/6 inhibitor towards market. While Kisqali showed impressive efficacy in the MONALEESA-2 study, Novartis will have its work cut out for it to catch Ibrance, which racked up $643 million in sales last year.
Last year, Novartis split off its oncology business from its pharmaceuticals division, a move designed to reflect the importance of cancer drugs to future growth.
Kisqali is a cornerstone of those plans. Breast cancer is one of the most common types of cancer in the U.S., with roughly 250,000 women diagnosed with invasive forms of the disease each year.
For now, Kisqali is only approved for a smaller subset of those patients, but approval in HR+, HER2- metastatic breast cancer is just the first step in Novartis’ plans for the drug. Two other registrational studies — MONALEESA-3 and MONALEESA-7 — are ongoing in other populations, with preliminary efficacy data expected in as soon as late 2017.
In the MONALEESA-2 trial, treatment with Kisqali and the aromatase inhibitor letrozole reduced the risk of progression or death by 44% over letrozole alone. At the time of an interim analysis, median progression-free survival (PFS) had not been reached, but a subsequent look with 11 more months of data showed a 9.3 month improvement in PFS.
Data like that will likely boost Kisqali’s commerical success, but the drug did have some safety concerns. Approval comes with a warning of QT interval progression and hepatobiliary toxicity, complications of the heart and liver, respectively.
Novartis plans to start shipping Kisqali to pharmacies as soon as tomorrow and will offer three doses, all on a 28-day treatment regimen. Wholesale acquisition cost (WAC) for a 28-day supply of the 600 mg dose is set at $10,950, while the 400 mg will cost $8,760 and the 200 mg will cost $4,380.
"At the time of launch, Kisqali will be the CDK 4/6 inhibitor with the lowest WAC price," Bill Hinshaw, head of US Oncology for Novartis said.
Pfizer’s rival Ibrance, which carries a similar (but broader) indication, has a strong head start, though. Pfizer estimates Ibrance has a 45% market share in first-line treatment of HR+, HER2- metastatic breast cancer and expects late-adopting doctors to drive growth further.