Swiss pharma giant, Novartis AG (NVS - Free Report) announced that the FDA has approved Kisqali, formerly known as ribociclib (LEE011), for use in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
So far this year, shares of Novartis are up 3.8%, underperforming the Zacks the classified Large Cap Pharmaceuticals industry, which gained 6.8% during the period.
The approval was based on positive data from the phase III of MONALEESA-2 trial, which evaluated the safety and efficacy of LEE011, a CDK4/6 inhibitor, in combination with letrozole, compared to letrozole alone. Data from the first pre-planned interim analysis of the study were presented in December last year. Data from the study demonstrated that LEE011 plus letrozole significantly prolonged progression-free survival (PFS), thereby meeting the primary endpoint, across pre-planned patient subgroups. Kisqali plus letrozole achieved a 44% reduction in risk of progression or death in comparison to letrizole alone.
The strength of LEE011, in combination with letrozole, in the first-line setting showed that treatment benefit was evident across all patient subgroups regardless of their disease burden or tumor location, including patients with aggressive disease.
Later, at a subsequent analysis with additional 11-month follow-up and progression events, Kisqali plus letrozole achieved a median PFS of 25.3 months compared to 16.0 months for letrozole alone. Overall survival data, which was not yet mature, will be available at a later date.
In a major boost to its already strong oncology portfolio of drugs, Kisqali will help Novartis take a pie of the growing breast cancer market, which is estimated to affect 2,50,000 women in 2017, per the American Cancer Society. It is estimated that up to one-third of the early stage breast cancer patients will subsequently develop metastatic disease.
We remind investors that Novartis broadened its oncology portfolio by acquiring GlaxoSmithKline plc’s (GSK - Free Report) certain oncology products and pipeline compounds in Mar 2015. In Oct 2015, it acquired a portfolio of cancer immunotherapies through the acquisition of Admune Therapeutics and added bispecific antibodies through a collaboration with Xencor, Inc. (XNCR - Free Report) in Jun 2016. It also has immune-oncology licensing agreements with Palobiofarma, Surface Oncology and XOMA Corporation (XOMA - Free Report)
Meanwhile, Novartis is evaluating Kisqali in multiple endocrine therapy combinations through phase III trials, MONALEESA-3 and MONALEESA-7
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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From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
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Swiss pharma giant, Novartis AG (NVS - Free Report) announced that the FDA has approved Kisqali, formerly known as ribociclib (LEE011), for use in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
So far this year, shares of Novartis are up 3.8%, underperforming the Zacks the classified Large Cap Pharmaceuticals industry, which gained 6.8% during the period.
The approval was based on positive data from the phase III of MONALEESA-2 trial, which evaluated the safety and efficacy of LEE011, a CDK4/6 inhibitor, in combination with letrozole, compared to letrozole alone. Data from the first pre-planned interim analysis of the study were presented in December last year. Data from the study demonstrated that LEE011 plus letrozole significantly prolonged progression-free survival (PFS), thereby meeting the primary endpoint, across pre-planned patient subgroups. Kisqali plus letrozole achieved a 44% reduction in risk of progression or death in comparison to letrizole alone.
The strength of LEE011, in combination with letrozole, in the first-line setting showed that treatment benefit was evident across all patient subgroups regardless of their disease burden or tumor location, including patients with aggressive disease.
Later, at a subsequent analysis with additional 11-month follow-up and progression events, Kisqali plus letrozole achieved a median PFS of 25.3 months compared to 16.0 months for letrozole alone. Overall survival data, which was not yet mature, will be available at a later date.
In a major boost to its already strong oncology portfolio of drugs, Kisqali will help Novartis take a pie of the growing breast cancer market, which is estimated to affect 2,50,000 women in 2017, per the American Cancer Society. It is estimated that up to one-third of the early stage breast cancer patients will subsequently develop metastatic disease.
We remind investors that Novartis broadened its oncology portfolio by acquiring GlaxoSmithKline plc’s (GSK - Free Report) certain oncology products and pipeline compounds in Mar 2015. In Oct 2015, it acquired a portfolio of cancer immunotherapies through the acquisition of Admune Therapeutics and added bispecific antibodies through a collaboration with Xencor, Inc. (XNCR - Free Report) in Jun 2016. It also has immune-oncology licensing agreements with Palobiofarma, Surface Oncology and XOMA Corporation (XOMA - Free Report)
Meanwhile, Novartis is evaluating Kisqali in multiple endocrine therapy combinations through phase III trials, MONALEESA-3 and MONALEESA-7
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
One has driven from 0 to a $68 billion valuation in 8 years. Four others are a little less obvious but already show jaw-dropping growth. Download this IPO Watch List today for free >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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