LENVIMA (Eisai Australia Pty Ltd)
Product name
LENVIMA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
54 working days (255)
Active ingredients
lenvatinib mesilate
Registration type
EOI
Indication
LENVIMA (hard capsules), in combination with pembrolizumab, is now also indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration