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Novartis' Tafinlar/Mekinist Combo Gets EU Nod for 3rd Disease

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Novartis AGNVS announced that he European Commission has approved its BRAF/MEK inhibitor combination, Tafinlar + Mekinist for the third cancer indication. The latest approval for the combination therapy is for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection.

The approval is based on data from the COMBI-AD study, which showed that the combination led to greater than 50% reduction in risk of disease recurrence or death in stage III melanoma patients. The Tafinlar + Mekinist combination was approved by the FDA for the same indication in April this year.

We note that an approval was in the cards as the Committee for Medicinal Products for Human Use (CHMP) had granted a positive opinion on the same in July.

Novartis' stock has declined 0.2% this year so far against the industry 's increase of 5.4%.

The Tafinlar + Mekinist combination is already approved in the United States and Europe for patients with unresectable or metastatic melanoma and metastatic NSCLC whose tumors tested positive for the BRAF V600 mutation. Both Tafinlar and Mekinist are also approved individually as single agents for the treatment of patients with unresectable or metastatic melanoma.

Novartis broadened its oncology portfolio by acquiring GlaxoSmithKline plc's GSK certain oncology products and pipeline compounds in March 2015 after divesting its Animal Health Division to Eli Lilly and Co. LLY . Both Tafinlar and Mekinist were acquired from Glaxo

In a separate press release, Novartis' eye care division, Alcon, announced that it is voluntarily recalling its CyPass Micro-Stent for surgical glaucoma from the global markets.

The decision is based on five-year data from the COMPASS-XT long-term safety study which showed cell loss in patients. The COMPASS-XT study was conducted to collect safety data from the participants of the COMPASS study on the basis of which the stent was approved two years back. Novartis has instructed physicians to immediately stop using the stent for implantation. Following the recall, Novartis intends to work with the FDA to identify any labeling changes, which will enable it to bring back the stent in the future.

Novartis currently has a Zacks Rank #4 (Sell).

A better-ranked large-cap drug stock is Bristol-Myers Squibb Company BMY , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Bristol-Myers' earnings estimates increased almost 5% for 2018 as well as 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 6.39%.

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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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