Novartis AG (NVS - Free Report) announced that the European Commission (EC) has approved breast cancer drug Kisqali (ribociclib).
The EC approved the drug in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.
We remind investors that Kisqali is the first CDK4/6 inhibitor approved in Europe. An approval was in the cards as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion in June 2017.
In March 2017, the FDA also approved Kisqali in combination with any aromatase inhibitor, as a treatment for metastatic breast cancer.
The drug in combination with letrozole was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a category 1 option for HR+/HER2 postmenopausal metastatic breast cancer patients.
Novartis stock has rallied 13.0% in the year so far compared with the industry’s 11.3% gain.
Novartis has a strong oncology portfolio of drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Jadenu and an improved formulation of Exjade.
The company is making significant progress on its immuno-oncology pipeline. The FDA Oncologic Drugs Advisory Committee has unanimously (10-0) recommended the approval of Novartis’ immunocellular therapy candidate CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). This provided a major boost to Novartis. CTL019 could become the first CAR-T cell therapy if approved. A potential approval will also open new frontiers in the treatment of cancer by advancing immunocellular therapy for children and young adults with r/r B-cell ALL.
We note that Roche Holding AG (RHHBY - Free Report) is a leading company in breast cancer drugs with a strong portfolio of drugs like Herceptin, Perjeta and Kadcyla.
Zacks Rank & Key Picks
Novartis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Gilead Sciences, Inc. (GILD - Free Report) and Aduro Biotech, Inc. (ADRO - Free Report) . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead’s earnings per share estimates increased from $8.31 to $8.75 for 2017, over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 6.38%.
Aduro Biotech’s loss per share estimates narrowed from $1.46 to $1.32 for 2017 and from $1.41 to $1.24 over the last 30 days. The company delivered positive surprises in two of the trailing four quarters with an average beat of 2.53%.
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