Approval Announcement
Woodcliff Lake, NJ and Kenilworth, NJ, Aug. 16, 2018 – Eisai Inc. and Merck (NYSE: MRK, known as MSD outside the U.S. and Canada) announced that the U.S. Food and Drug Administration (FDA) has approved Lenvima (lenvatinib), a kinase inhibitor, for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
Basis for Approval: REFLECT (Study 304)
The approval is based on data from the REFLECT (Study 304) trial, which compared Lenvima with sorafenib in patients with previously untreated unresectable HCC. Key trial results include:
Overall Survival (OS): Lenvima demonstrated a proven treatment effect, with statistical confirmation of non-inferiority to sorafenib.
Progression-Free Survival (PFS): Statistically significant superiority of Lenvima compared to sorafenib.
Objective Response Rate (ORR): Clinically meaningful improvements in ORR with Lenvima versus sorafenib.
Expert Commentary
“Unresectable hepatocellular carcinoma is an extremely difficult-to-treat cancer, with no new first-line systemic therapy options for more than a decade,” said Dr. Ghassan Abou-Alfa, medical oncologist at Memorial Sloan Kettering Cancer Center. “REFLECT is the first-ever positive Phase 3 trial against an active comparator in unresectable HCC. The efficacy and safety data from REFLECT are important findings for oncologists and others in the multidisciplinary teams who treat liver cancer, as well as for our patients who are affected by it.”
Safety Profile
Lenvima is associated with potential adverse reactions, some of which may be severe or fatal, requiring careful monitoring and appropriate management.
Adverse Reactions (Severe or Fatal Possible)
Hypertension, cardiac dysfunction, arterial thromboembolic events
Hepatotoxicity, renal failure or impairment, proteinuria
Diarrhea, fistula formation and gastrointestinal perforation
QT interval prolongation, hypocalcemia
Reversible posterior leukoencephalopathy syndrome, hemorrhagic events
Impairment of thyroid stimulating hormone suppression/thyroid dysfunction
Wound healing complications
Management and Safety Precautions
Treatment Management: Based on the severity of the adverse reaction, Lenvima should be monitored, withheld, or discontinued.
Fetal Harm: Based on its mechanism of action and animal reproduction studies, Lenvima can cause fetal harm when administered to pregnant women.
Contraception Advice: Females of reproductive potential should be advised to use effective contraception.
