FDA expands approval of Eisai, Merck & Co.'s Lenvima for patients with unresectable HCC

The FDA expanded the label for Eisai and Merck & Co.'s oral therapy Lenvima (lenvatinib) to include the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC), the drugmakers announced Thursday. Roy Baynes, head of global clinical development at Merck Research Laboratories, said "we are pleased by the FDA approval of Lenvima as it marks an important advancement in the treatment of unresectable [HCC]." 

The FDA noted that approval was supported by data from the Phase III REFLECT trial of 954 patients with previously untreated, metastatic or unresectable HCC. Results unveiled earlier this year demonstrated that Lenvima was non-inferior, but not statistically superior to Bayer's Nexavar (sorafenib) for overall survival (OS), with patients achieving a median OS of 13.6 months and 12.3 months in the Lenvima and Nexavar groups, respectively. Lenvima was also associated with significant improvement in progression-free survival at 7.3 months, compared with 3.6 months for Nexavar.

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Lenvima was initially approved in the US in 2015 for the treatment of certain patients with progressive, differentiated thyroid cancer. The drug's indication was later expanded to include advanced renal cell carcinoma in combination with Novartis' Afinitor (everolimus) in patients who previously received an anti-angiogenic therapy. 

Merck reached a deal with Eisai earlier this year under which the companies will co-develop and co-market Lenvima, both as monotherapy and in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab), for multiple cancer types. Last month, the FDA granted breakthrough therapy status to the combination of Lenvima and Keytruda for patients with advanced and/or metastatic non-microsatellite instability high/proficient mismatch repair endometrial carcinoma who progressed after at least one previous systemic therapy. 

Analysts, who forecast revenue of nearly $3.5 billion for Lenvima by 2022, have suggested that wider adoption of the drug could provide another "reasonable source of support" for Merck amid investor concerns about the company's reliance on Keytruda. Eisai indicated that "the price at which the recommended starting dose of Lenvima for unresectable HCC will be sold to wholesalers, excluding discounts, is $15 970 for a 30-day supply."

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