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LENVIMA (lenvatinib)
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Mar 24 2020
Reason for request
Extension of indication
Insufficient clinical benefit as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
- LENVIMA has an MA as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.
- The non-inferiority of lenvatinib was demonstrated in comparison with sorafenib in terms of overall survival, but not its superiority. The transposability of the results of this study to the French population is not guaranteed. The frequency of serious adverse events, grade ≥ 3 adverse events and deaths is higher in the lenvatinib group than in the sorafenib group. It is not possible to identify those patients who may not be given sorafenib but who would be eligible for lenvatinib. Consequently, LENVIMA has no role in the care pathway in adult patients with advanced or unresectable HCC who have received no prior systemic therapy.
Clinical Benefit
| Insufficient |
- |
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