Click Here to
Subscribe
Breaking
News, Updates,
& More
Stay Up
to Date

Lenvima Now Approved for Unresectable Hepatocellular Carcinoma

Web Exclusives - FDA Updates

On August 16, 2018, the FDA approved lenvatinib (Lenvima; Eisai) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

This approval was based on the multicenter, randomized, open-label, noninferiority REFLECT clinical trial of 954 patients with untreated metastatic or unresectable HCC. Patients were randomized in a 1:1 ratio to lenvatinib or to sorafenib (Nex­avar) until radiologic disease progression or unacceptable toxicity.

The median overall survival was 13.6 months with lenvatinib versus 12.3 months with sorafenib (hazard ratio, 0.92; 95% confidence interval, 0.79-1.06).

The median progression-free survival with lenvatinib was 7.3 months versus 3.6 months with sorafenib (P <.001). The overall response rate was 41% with lenvatinib versus 12% with sorafenib.

The most common (≥20%) adverse events with lenvatinib were hypertension, fatigue, diarrhea, decreased appetite, arthralgia or myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.

Related Items
Recent Cancer Drugs Approved by the FDA 2020
JHOP - February 2020 Vol 10, No 1 published on February 19, 2020 in FDA Updates
FDA Grants Priority Review to New Drug Application for the RET Kinase Inhibitor Selpercatinib
Web Exclusives published on February 4, 2020 in FDA Updates, In the News, Lung Cancer, Thyroid Cancer
Tazverik Receives FDA Approval as First Treatment Specifically for Metastatic or Locally Advanced Epithelioid Sarcoma
Web Exclusives published on January 28, 2020 in FDA Updates, In the News, Sarcoma
FDA Grants Approval to Avapritinib for Patients with GIST
Web Exclusives published on January 13, 2020 in FDA Updates, Gastrointestinal Cancers, In the News, Rare Cancers
Recap of FDA Drug Approvals in 2019
Web Exclusives published on January 7, 2020 in FDA Updates, In the News
December 19, 2019 - FDA News & Updates
Web Exclusives published on December 17, 2019 in Drug Updates, FDA Updates
Regenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for Synovial Sarcoma
Web Exclusives published on December 11, 2019 in FDA Updates, In the News, Sarcoma
FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer
Web Exclusives published on December 3, 2019 in Bladder Cancer, FDA Updates, Immunotherapy
Inrebic Receives FDA Approval for Adults with Myelofibrosis
Web Exclusives published on December 2, 2019 in FDA Updates
FDA Approved Erleada for Metastatic Castration-Sensitive Prostate Cancer
Web Exclusives published on December 2, 2019 in FDA Updates
Last modified: February 19, 2019