We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Novartis' (NVS) Kisqali Gets FDA Nod for Label Expansion
Read MoreHide Full Article
Novartis AG (NVS - Free Report) announced that the FDA has expanded oncology drug Kisqali’s label.
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.
However, competition is stiff in the breast cancer market with the likes of Roche (RHHBY - Free Report) .
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 , covering development, registration and commercialization rights to voretigene neparvovec, outside the United States.
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
Image: Bigstock
Novartis' (NVS) Kisqali Gets FDA Nod for Label Expansion
Novartis AG (NVS - Free Report) announced that the FDA has expanded oncology drug Kisqali’s label.
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.
However, competition is stiff in the breast cancer market with the likes of Roche (RHHBY - Free Report) .
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 , covering development, registration and commercialization rights to voretigene neparvovec, outside the United States.
Zacks Rank
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>