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Novartis Reports Positive Data on Breast Cancer Drug Kisqali

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Novartis AG (NVS - Free Report) announced positive data from the phase III study, MONALEESA-2 on breast cancer drug Kisqali.

The study reinforced the efficacy and safety of Kisqali plus letrozole in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

A median progression-free survival (PFS) of 25.3 months for Kisqali plus letrozole and 16.0 months for letrozole were observed after an additional 11 months of follow up. Moreover, after two years of treatment, the progression-free survival rate was 54.7% in the Kisqali plus letrozole arm compared with 35.9% in patients treated with letrozole alone.

The data also showed that the safety profile of Kisqali plus letrozole remained consistent and the incidence of laboratory and electrocardiogram irregularities is similar to that observed at the first interim analysis.

Meanwhile, Novartis continues to evaluate Kisqali in multiple trials, in combination with different hormonal therapies, across a broad range of patients.

Earlier in 2017, the FDA approved Kisqali in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer.

However, stiff competition in the breast cancer markert is a deterrent. Roche (RHHBY - Free Report) with drugs like Herception, Perjeta and Kadcyla continues to pose challenge.

Novartis has a strong oncology portfolio of drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Jadenu and an improved formulation of Exjade.

Earlier in the month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of a label expansion of Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.

Novartis’ has outperformed the Zacks classified industry year to date. The stock has rose 12.6% compared with the Large Cap Pharmaceuticals industry’s gain of 10.6%.

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 after having divested its Animal Health Division to Eli Lilly and Company (LLY - Free Report) .

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.

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