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Novartis (NVS) Announces Data on Leukemia Drug Tasigna

Novartis AGNVS announced results from the Treatment-free Remission (TFR) program on oncology drug, Tasigna.

The program comprised two open-label trials - ENESTfreedom and ENESTop - that evaluated Tasigna's potential of maintaining molecular response (MR) after stopping therapy in the chronic phase in adult patients suffering from Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

In the ENESTfreedom trial, 51.6% of eligible first-line Tasigna patients maintained TFR for 48 weeks after stopping treatment. The study, however, did not meet its statistical primary endpoint. On the other hand, ENESTop met the primary endpoint, with 57.9% of eligible patients who had switched to Tasigna from Glivec maintaining TFR for 48 weeks after treatment cessation. The company expects to submit the results to regulatory authorities later in 2016.

We note that Tasigna is already approved for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy.

Last week, Novartis announced that the European Commission has approved Afinitor tablets for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin, in adults with progressive disease. An approval was on the cards as the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had given a positive opinion for the same.

In Feb 2016, the FDA approved Afinitor for the treatment of adult patients with progressive, well-differentiated nonfunctional NET of GI or lung origin. Afinitor is also approved for locally advanced, metastatic or unresectable progressive NET of pancreatic origin in both the U.S. and Europe.

Approval of new drugs and label expansion of existing ones bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Diovan and Gleevec. Additionally, its oncology drugs are facing competition from immuno-oncology therapies. Moreover, its Alcon segment is facing a decline in surgical equipment sales in the U.S. and emerging markets.

Novartis currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Pfizer Inc. PFE , Johnson & Johnson JNJ and Abbott Laboratories ABT . While Pfizer sports a Zacks Rank #1 (Strong Buy), Johnson & Johnson and Abbott Labs carry a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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