Back to top

Eisai and Merck Announce Update on Lenvatinib sNDA Review

Read MoreHide Full Article

Eisai Inc., a subsidiary of Japan-based Eisai Co. (ESALY - Free Report) ,and partner Merck (MRK - Free Report) announced that the FDA has extended the review period of its supplemental New Drug Application (sNDA) for its cancer drug, lenvatinib, by three months to Aug 24, 2018. Currently, the company is looking to get lenvatinib approved for first-line treatment of patients with unresectable hepatocellular carcinoma (“HCC”), commonly known as liver cancer.

The FDA had accepted the sNDA in September last year. The regulatory body has now extended the review period as it requires additional time for review of the application. Eisai being the marketing authorization holder is working with the FDA to support the continuation of the review process.

The drug received its first approval for this indication in Japan in March.

Lenvima is approved as a single agent for treating differentiated thyroid cancer and in combination with Novartis’ (NVS - Free Report) chemo drug, Afinitor (everolimus), for advanced renal cell carcinoma following one prior anti-angiogenic therapy.

Eisai’s shares are up 27.1% so far this year, which compares favorably with an increase of 1% registered by the industry during this period.

The sNDA includes data from a phase III study, which compared lenvatinib with Bayer’s (BAYRY - Free Report) chemo drug, Nexavar (sorafenib). The candidate demonstrated non-inferiority in overall survival in treating liver cancer patients who have not received any prior treatment. The drug also achieved statistically significant and clinically meaningful improvements in progression-free survival, time to progression and objective response rate.

Eisai entered into a strategic collaboration with Merck in March to develop lenvatinib as single agent and in combination with Merck’s anti-PD-1 therapy, Keytruda, as well.

Eisai currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Looking for Stocks with Skyrocketing Upside?

Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.

Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.

See the pot trades we're targeting>>




In-Depth Zacks Research for the Tickers Above


Normally $25 each - click below to receive one report FREE:


Novartis AG (NVS) - free report >>

Merck & Co., Inc. (MRK) - free report >>

Bayer Aktiengesellschaft (BAYRY) - free report >>

Eisai Co. (ESALY) - free report >>


More from Zacks Analyst Blog

You May Like