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Merck, Eisai Get EU Approval for Lenvima Label Expansion
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Merck and Co., Inc. (MRK - Free Report) along with Japanese partner Eisai Co., Ltd. announced that their oral receptor tyrosine kinase inhibitor, Lenvima (lenvatinib), has received approval in the EU for an expanded indication. Lenvima, as a monotherapy,has received a marketing authorizationfrom the European Commission for first-line treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer, which is difficult to treat.
In the United States, Lenvima was approved for the same indication last week.
Shares of Merck have rallied 22.5% year to date against the industry’s decline of 5.3%.
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).
Liver cancer is the second most leading cause for cancer-related deaths with an estimate of 750,000 deaths recorded per year worldwide and 69,000 in Europe annually. Hence, this nod for Lenmiva in Europe can help Merck address a market with significant unmet need which can drive sales of the drug higher.
Lenvima was first approved for HCC indication in Japan this March. 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.
In the United States, Lenvima is already approved as a monotherapy for the treatment of metastatic iodine-refractory differentiated thyroid cancer and advanced renal cell carcinoma (RCC) in combination with Novartis’ (NVS - Free Report) Afinitor (everolimus). Also, late-stage studies are already under way to evaluate Lenvima in separate combination trials 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.
Merck’s alliance revenues from from AstraZeneca and Eisai for Lynparza and Lenvima, respectively, boosted the company’s oncology sales during the second quarter of 2018. Lynparza alliance revenues were $44 million in the second quarter while Lenvima alliance revenues were $35 million.
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Merck, Eisai Get EU Approval for Lenvima Label Expansion
Merck and Co., Inc. (MRK - Free Report) along with Japanese partner Eisai Co., Ltd. announced that their oral receptor tyrosine kinase inhibitor, Lenvima (lenvatinib), has received approval in the EU for an expanded indication. Lenvima, as a monotherapy,has received a marketing authorizationfrom the European Commission for first-line treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer, which is difficult to treat.
In the United States, Lenvima was approved for the same indication last week.
Shares of Merck have rallied 22.5% year to date against the industry’s decline of 5.3%.
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).
Liver cancer is the second most leading cause for cancer-related deaths with an estimate of 750,000 deaths recorded per year worldwide and 69,000 in Europe annually. Hence, this nod for Lenmiva in Europe can help Merck address a market with significant unmet need which can drive sales of the drug higher.
Lenvima was first approved for HCC indication in Japan this March. 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.
In the United States, Lenvima is already approved as a monotherapy for the treatment of metastatic iodine-refractory differentiated thyroid cancer and advanced renal cell carcinoma (RCC) in combination with Novartis’ (NVS - Free Report) Afinitor (everolimus). Also, late-stage studies are already under way to evaluate Lenvima in separate combination trials 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.
Merck’s alliance revenues from from AstraZeneca and Eisai for Lynparza and Lenvima, respectively, boosted the company’s oncology sales during the second quarter of 2018. Lynparza alliance revenues were $44 million in the second quarter while Lenvima alliance revenues were $35 million.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. Price and Consensus | Merck & Co., Inc. Quote
Zacks Rank
Merck carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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