FDA Grants Approval to Lenvatinib as First-Line Therapy for Hepatocellular Carcinoma
The FDA based its approval on data from the REFLECT phase 3 study in which investigators enrolled 954 previously untreated patients with metastatic or unresectable hepatocellular carcinoma.
The US Food and Drug Administration (FDA) granted approval to lenvatinib capsules as a first-line therapeutic option for the treatment of patients with unresectable hepatocellular carcinoma (HCC), according to a press release.1
The FDA based its approval on data from the REFLECT phase 3 (ClinicalTrials.gov Identifier: NCT01761266) study in which investigators enrolled 954 previously untreated patients with metastatic or unresectable HCC. Patients were assigned to receive lenvatinib 12 mg daily for baseline bodyweight 60 kg or more and 8 mg for less than 60 kg, or sorafenib 400 mg twice daily.
Results showed that patients in the lenvatinib arm had a median overall survival (OS) of 13.6 months compared with 12.3 months in the sorafenib arm, demonstrating non-inferiority (hazard ratio [HR], 0.92; 95% CI, 0.79-1.06). Patients treated with lenvatinib also had significantly improved progression-free survival (PFS), with median PFS of 7.3 months versus 3.6 months among patients treated with sorafenib (HR, 0.64; 95% CI, 0.55-0.75; P < .001). The overall response rate was also greater in the lenvatinib arm with 41% compared with 12% in the sorafenib arm.
The most commonly reported adverse events among lenvatinib-treated patients included hypertension, fatigue, nausea, diarrhea, abdominal pain, decreased appetite, arthralgia/myalgia, decreased weight, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, and hypothyroidism.
- FDA approves lenvatinib for unresectable hepatocellular carcinoma [press release]. Silver Springs, MD: US Food and Drug Administration; Updated August 16, 2018. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617185.htm. Accessed August 16, 2018.