Lenvima® (lenvatinib) has been granted not only one, but two approvals these past two weeks! The first one came on August 16, from the FDA, and only a week later, a second approval came from the European Commission.
In the US, the FDA approved Lenvima® for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). In Europe, the European Commission approved it for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.
Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It accounts for about 90% of all liver cancer cases. It is an extremely difficult-to-treat cancer, and there has not been a new first-line treatment option for more than 10 years, according to manufacturers Eisai and Merck (MSD outside the US).
The two approvals of Lenvima®
Both the approval from the FDA and the approval from the European Commission were based on data from a Phase 3 clinical trial called REFLECT. The trial involved 954 patients with previously untreated unresectable HCC. In the trial, Lenvima® was compared to the current standard of care; sorafenib.
In terms of overall survival, Lenvima® showed non-inferiority when compared to sorafenib (13.6 months compared to 12.3 months). As for progression-free survival, there was a bigger difference. Here, Lenvima® showed a PFS of 7.3 months compared to 3.6 months for sorafenib.
Lastly, in terms of overall response rate (ORR), the data from the trial showed an ORR of 41% compared to 12% for sorafenib.
Besides this new approval as first-line treatment in HCC, Lenvima® (lenvatinib) is approved by the FDA for the treatment of patients with advanced renal cell carcinoma in combination with everolimus. Furthermore, it is approved for the treatment of patients with differentiated thyroid cancer.
Lenvima® is a registered trademark of Eisai Inc. and Merck (MSD outside of the US).