Case Study on USFDA Label Expansion: Novartis’ Kisqali

• FDA had approved Kisqali in tandem with an aromatase inhibitor as an initial endocrine-based treatment for pre, peri- or postmenopausal women with hormone receptor-positive, HER2-negative breast cancer.
• Consequently, Kisqali is now the only CDK4/6 inhibitor, indicated for use with an aromatase inhibitor for the treatment of pre-, peri- or post-menopausal women in the United States.
• The drug is also approved for use in combination with Faslodex as both first- or second-line therapy in postmenopausal women.

sNDA submission: 

The supplemental New Drug Application (sNDA) submitted by Novartis was reviewed by the FDA under its Real-Time Oncology Review and Assessment Aid pilot programs. The agency approved the application in less than one month after submission.

Benefit of label expansion:

The label expansion will increase the market potential of the drug, as approximately 155,000 patients in the United States are living with metastatic breast cancer. Kisqali was certainly not doing well at present and lagging behind head to head with Pfizer blockbuster Ibrance and Eli Lilly newcomer Verzenio. But this label expasion will definitely provide the sales edge for  Kisqali.

Approval History:

Kisqali was initially approved by the FDA in March 2017 and by the European Commission in August 2017, as initial endocrine-based therapy for post-menopausal women with HR+/HER2- locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial.