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Novartis' Tafinlar, Mekinist Get EU Approval for NSCLC
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Novartis AG (NVS - Free Report) recently announced that the European Commission has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC).
A look at Novartis’ share price movement over the past one year shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. Novartis’ stock rallied 2.1% during this period, while the industry gained 6.0%.
We note that an approval was on the cards as the Committee for Medicinal Products for Human Use (CHMP) had granted a positive opinion on the same in Feb 2017.
Per estimates, approximately 36,000 people throughout the world, or about 1–3% of patients suffering from lung cancer, are diagnosed with BRAF V600-positive NSCLC.
We remind investors that the FDA has granted Tafinlar + Mekinist the Breakthrough Therapy designation for advanced or metastatic BRAF V600E-positive NSCLC patients in 2015 and priority review for the same was granted in Nov 2016.
The combination is already approved in the U.S. and Europe for patients with unresectable or metastatic melanoma whose tumors tested positive for the BRAF V600 mutation.
We note that Novartis is also evaluating Zykadia for the treatment of ALK+NSCLC and the company has submitted applications in the U.S. and EU in Dec 2016.
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) . In Oct 2015, it acquired a portfolio of cancer immunotherapies through the acquisition of Admune Therapeutics and added bispecific antibodies through a collaboration with Xencor, Inc. (XNCR - Free Report) in Jun 2016.
Going forward, we expect approval of new drugs and label expansion of existing ones to bode well for Novartis. Also, strong performance of growth products should be able to offset the impact of generic competition for Gleevec.
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Novartis' Tafinlar, Mekinist Get EU Approval for NSCLC
Novartis AG (NVS - Free Report) recently announced that the European Commission has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC).
A look at Novartis’ share price movement over the past one year shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. Novartis’ stock rallied 2.1% during this period, while the industry gained 6.0%.
We note that an approval was on the cards as the Committee for Medicinal Products for Human Use (CHMP) had granted a positive opinion on the same in Feb 2017.
Per estimates, approximately 36,000 people throughout the world, or about 1–3% of patients suffering from lung cancer, are diagnosed with BRAF V600-positive NSCLC.
We remind investors that the FDA has granted Tafinlar + Mekinist the Breakthrough Therapy designation for advanced or metastatic BRAF V600E-positive NSCLC patients in 2015 and priority review for the same was granted in Nov 2016.
The combination is already approved in the U.S. and Europe for patients with unresectable or metastatic melanoma whose tumors tested positive for the BRAF V600 mutation.
We note that Novartis is also evaluating Zykadia for the treatment of ALK+NSCLC and the company has submitted applications in the U.S. and EU in Dec 2016.
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) . In Oct 2015, it acquired a portfolio of cancer immunotherapies through the acquisition of Admune Therapeutics and added bispecific antibodies through a collaboration with Xencor, Inc. (XNCR - Free Report) in Jun 2016.
Going forward, we expect approval of new drugs and label expansion of existing ones to bode well for Novartis. Also, strong performance of growth products should be able to offset the impact of generic competition for Gleevec.
Novartis currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>