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Novartis Breast Cancer Drug OK'd by FDA as First-line Therapy

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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.

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