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.
Kisqali is now approved in the United States for the treatment of women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic 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.
The approval was based on positive data from MONALEESA-3 and MONALEESA-7 trials, which demonstrated robust efficacy of Kisqali combination therapy in multiple treatment partners and settings.
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.
We remind investors that 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.
Novartis is also evaluating Kisqali for the treatment of early breast cancer (EBC). A phase III trial, NATALEE, is evaluating Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- EBC.
Kisqali’s uptake in the United States is encouraging and the drug will be launched in some EU countries as well. Novartis expects additional markets in Europe to gain reimbursement over the next 12 months. Meanwhile, filings are underway with other health authorities worldwide.
Approval of new drugs and label expansion of key drugs bode well for Novartis. The company recently reported second-quarter results where it beat sales estimates on strong performance of Cosentyx and Entresto.
Novartis’ stock has declined 0.2% in the year so far compared with the industry‘s 1.6% growth.
Novartis has restructured its business and plans to focus on becoming a core drug-focused company, powered by data and digital technologies. The company is looking to spin-off its ophthalmology division, Alcon. Novartis also divested its stake in the OTC joint venture with GlaxoSmithKline (GSK – Free Report) for $13 billion.
Novartis intends to solidify its presence in the gene therapy space. Earlier in 2018, it announced a licensing agreement with Spark Therapeutics (ONCE – Free Report) , covering development, registration and commercialization rights to voretigene neparvovec, outside the United States.
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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