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Novartis' Systemic Mastocytosis Drug Positive in Phase II

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Novartis AG (NVS - Free Report) announced that data from its phase II study, CPKC412D2201, on PKC412 (midostaurin) was published in The New England Journal of Medicine.

The open-label study enrolled adults (aged 18 years and above) who had the following subtypes of advanced systemic mastocytosis (SM) in the primary efficacy population – aggressive systemic mastocytosis, mast cell leukemia, and SM with an associated hematologic neoplasm. Patients enrolled in the trial received single-agent oral administration of PKC412 until disease progression or unacceptable toxicity.

Data demonstrated an overall response rate of 60% in patients suffering from SM. Results showed a median overall survival of 28.7 months, along with improvements in both bone marrow mast cell burden and serum tryptase levels.

We note that the FDA has recently granted Breakthrough Therapy designation to PKC412 for the treatment of adults with newly-diagnosed FLT3-mutated acute myeloid leukemia (AML). The candidate also enjoys Orphan Drug status in the EU and the U.S. for both AML and mastocytosis.

Advanced SM is rare and has a poor prognosis. As per the European Journal of Hematology, there is currently no approved treatment for the majority of patients suffering from the disease. Hence, the successful development and commercialization of PKC412 will bode well for Novartis.

We believe investors should look out for approval of new drugs and label expansion of existing ones at Novartis as the company has been facing stiff generic competition for some of its key drugs like Diovan and Gleevec. This apart, its oncology drugs are facing competition from immuno-oncology therapies. Moreover, its Alcon segment is witnessing a decline in surgical equipment sales in the U.S. and emerging markets.

Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Pfizer, Inc. (PFE - Free Report) , Bristol-Myers Squibb Co. (BMY - Free Report) and Johnson & Johnson (JNJ - Free Report) . While Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Johnson & Johnson is a Zacks Rank #2 (Buy) stock.

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