Eisai Inc., a subsidiary of Japan-based Eisai Co. (OTC:ESALY) ,and partner Merck (NYSE:MRK) 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’ (NYSE:NVS) 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 (OTC:BAYRY) 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.
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