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Merck, Eisai Get FDA Approval for Lenvima Label Expansion
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Merck and Co., Inc. (MRK - Free Report) along with its Japanese partner Eisai Co., Ltd. announced that their tyrosine kinase inhibitor, Lenvima (lenvatinib) has received FDA approval for an expanded indication. Lenvima, has been approved by the FDA for first-line treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer which is difficult to treat.
The approval was based on positive data from a phase III REFLECT study (Study 304), which showed that Lenvima demonstrated statistically significant non-inferiority of overall survival (OS) (13.6 months) compared with Bayer AG’s (BAYRY - Free Report) Nexavar (sorafenib) (12.3 months). The study also showed that Lenvima demonstrated highly statistically significant and clinically meaningful improvements as compared to Nexavar in the secondary endpoints of progression-free survival and objective response rate (ORR).
We would like to remind investors that the FDA accepted the supplemental new drug application (sNDA) for the Lenvima last September. However, the regulatory body extended its review period by three months to Aug 24, 2018. The approval came before the stipulated time.
Lenvima received its first approval for HCC indication in Japan in March 2018. Eisai entered into a strategic collaboration with Merck in the same month to develop Lenvima as a single agent as well as in combination with Merck’s anti-PD-1 therapy, Keytruda.
Presently, Lenvima is approved as a monotherapy for the treatment of metastatic iodine-refractory differentiated thyroid cancer and advanced renal cell carcinoma in combination with Novartis’ (NVS - Free Report) Afinitor (everolimus). Also, late-stage studies are already under way to evaluate Lenvima in separate combination studies with Keytruda and Afinitor for RCC. The Keytruda/Lenvima combination enjoys a Breakthrough Therapy Designation from the FDA for treating RCC.
Similar to the Eisai deal, Merck has a co-development and commercialization agreement with Swiss pharma giant AstraZeneca (AZN - Free Report) for PARP inhibitor Lynparza and MEK 1/2 inhibitor, selumetinib.
Shares of Merck have rallied 22.3% year to date, substantially outperforming the industry’s increase of 2.8%.
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Merck, Eisai Get FDA Approval for Lenvima Label Expansion
Merck and Co., Inc. (MRK - Free Report) along with its Japanese partner Eisai Co., Ltd. announced that their tyrosine kinase inhibitor, Lenvima (lenvatinib) has received FDA approval for an expanded indication. Lenvima, has been approved by the FDA for first-line treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer which is difficult to treat.
The approval was based on positive data from a phase III REFLECT study (Study 304), which showed that Lenvima demonstrated statistically significant non-inferiority of overall survival (OS) (13.6 months) compared with Bayer AG’s (BAYRY - Free Report) Nexavar (sorafenib) (12.3 months). The study also showed that Lenvima demonstrated highly statistically significant and clinically meaningful improvements as compared to Nexavar in the secondary endpoints of progression-free survival and objective response rate (ORR).
We would like to remind investors that the FDA accepted the supplemental new drug application (sNDA) for the Lenvima last September. However, the regulatory body extended its review period by three months to Aug 24, 2018. The approval came before the stipulated time.
Lenvima received its first approval for HCC indication in Japan in March 2018. Eisai entered into a strategic collaboration with Merck in the same month to develop Lenvima as a single agent as well as in combination with Merck’s anti-PD-1 therapy, Keytruda.
Presently, Lenvima is approved as a monotherapy for the treatment of metastatic iodine-refractory differentiated thyroid cancer and advanced renal cell carcinoma in combination with Novartis’ (NVS - Free Report) Afinitor (everolimus). Also, late-stage studies are already under way to evaluate Lenvima in separate combination studies with Keytruda and Afinitor for RCC. The Keytruda/Lenvima combination enjoys a Breakthrough Therapy Designation from the FDA for treating RCC.
Similar to the Eisai deal, Merck has a co-development and commercialization agreement with Swiss pharma giant AstraZeneca (AZN - Free Report) for PARP inhibitor Lynparza and MEK 1/2 inhibitor, selumetinib.
Shares of Merck have rallied 22.3% year to date, substantially outperforming the industry’s increase of 2.8%.
Merck carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. Price and Consensus | Merck & Co., Inc. Quote
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Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
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