Novartis' (NVS) Tasigna Receives Label Update Nod in EU
Novartis AG NVS announced that the European Commission (EC) has approved the inclusion of Treatment-free Remission (TFR) data in the oncology drug Tasigna’s Summary of Product Characteristics (SmPC).
We note that Tasigna is approved for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to at least one prior therapy, including Gleevec. Also, it is approved for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase.
TFR helps in maintaining molecular response (MR) after stopping tyrosine kinase inhibitor (TKI) therapy in Ph+CMIL patients in chronic phase. The approval was based on efficacy and safety findings from the 48-week analyses of two open label trials, ENESTfreedom and ENESTop by the European Commission.
Novartis is evaluating more than 1,000 patients as part of the Tasigna TFR studies, which include ENESTfreedom and ENESTop along with two other ongoing company-sponsored TFR studies and multiple investigator-initiated studies.
Novartis has a strong oncology portfolio of drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Jadenu and an improved formulation of Exjade. Novartis broadened its oncology portfolio by acquiring GlaxoSmithKline plc’s GSK certain oncology products and pipeline compounds in Mar 2015 after having divested its Animal Health Division to Eli Lilly and Co. LLY.
Novartis’ has outperformed the Zacks classified industry year to date. The stock has rallied 12.3% compared with the Large Cap Pharmaceuticals industry’s gain of 10.4%.
Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis. The recent FDA approval of Kisqali, 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 will further boost the oncology portfolio.
Meanwhile, the FDA approved a label expansion of Zykadia to include the first-line treatment of patients with metastatic non-small cell lung cancer. Also, strong performance of growth products should be able to offset the impact of generic competition for Gleevec.
Zacks Rank & Key Pick
Novartis currently carries a Zacks Rank #3 (Hold).
A top-ranked stock in healthcare sector include VIVUS, Inc. VVUS which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’s loss per share estimates lessened from 50 cents to 39 cents for 2017 in the last 60 days. The company posted positive earnings surprises in all four trailing quarters with average beat of 233.69%.
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