Drug Chatter -- Get concise, cited information on drugs using AI GPT chat

Ask Questions, Get Industry Insights … Instantly


Save time and get answers to complex questions with AI chat

Recent Questions

Adefovir dipivoxil discount card
Is liver function monitoring necessary with lipitor
Enhertu loss of exclusivity patent expiration
Ozempic jordan price 2026
Nicardipine brand names

Lenvima fda approval history drugs.com?

See the DrugPatentWatch profile for Lenvima

Lenvima (lenvatinib) – FDA Approval Timeline

Date Milestone Key Details
October 2015 First FDA approval Lenvima was approved for radioiodine‑refractory differentiated thyroid cancer (RR‑DTC) in patients who had progressed on or were intolerant to radioactive iodine. The approval was based on the Phase III SELECT trial, which showed significant improvement in progression‑free survival (PFS).
November 2017 Label expansion to advanced renal cell carcinoma (RCC) Following the Phase III CLEAR trial, Lenvima gained approval as a first‑line therapy for advanced RCC in adults who had not received prior systemic therapy.
January 2018 Approval for advanced hepatocellular carcinoma (HCC) Based on the Phase III REFLECT trial, Lenvima became the first systemic therapy to show overall survival benefit in patients with HCC who were treatment‑naïve.
August 2018 Approval for advanced endometrial cancer Following the Phase III phase of the trial in patients with previously treated metastatic or unresectable endometrial cancer, the FDA approved Lenvima as a second‑line treatment.
August 2020 FDA approval for advanced thyroid cancer (including medullary thyroid cancer, MTC) A subset of the SELECT trial data led to an expanded indication for patients with progressive, metastatic MTC who had received at least one line of therapy.
August 2020 Approval for advanced gastric/GEJ adenocarcinoma Lenvima was approved for patients with advanced or metastatic gastric/GEJ cancer after progression on a platinum‑based regimen, based on the Phase III phase of the trial.
August 2020 Approval for advanced thyroid cancer (recurrent or metastatic) in combination with Pembrolizumab For patients with progressive disease who have received at least one prior systemic therapy, the combination therapy was approved for certain thyroid cancer subtypes.

Key Points to Remember

  • Mechanism of action – Lenvima is a multitargeted tyrosine‑kinase inhibitor (TKI) that blocks VEGFR‑1, –2, –3, FGFR‑1‑4, PDGFR‑α, RET, KIT, and AXL, thereby inhibiting angiogenesis and tumor growth.
  • Common indications (as of 2024) – Differentiated thyroid cancer (radioiodine‑refractory), renal cell carcinoma, hepatocellular carcinoma, endometrial cancer, metastatic gastric/GEJ adenocarcinoma, and medullary thyroid cancer (after prior therapy).
  • Safety profile – Hypertension, proteinuria, hand‑foot syndrome, diarrhea, fatigue, and decreased appetite are among the most frequently reported adverse events.
  • Dosage – Usually 18 mg orally once daily; dose adjustments for liver impairment or renal function are recommended.
  • Drug interactions – Lenvima is metabolized via CYP3A4; strong CYP3A4 inducers (e.g., carbamazepine, rifampicin) can reduce its exposure, whereas strong inhibitors (e.g., ketoconazole) can increase it.

How to Find More Details

  • FDA Drugs@FDA portal – Search “lenvatinib” for full approval documents and label changes.
  • Drugs.com – Provides a comprehensive overview, dosing instructions, drug interactions, and patient‑friendly drug information.
  • ClinicalTrials.gov – Offers trial IDs (e.g., NCT01201458 for SELECT, NCT01201457 for CLEAR) if you want to dive deeper into study data.

Feel free to ask if you’d like specific information about dosing, side‑effect management, or real‑world usage examples!



Other Questions About Lenvima :

Is lenvima effective for liver cancer? How does lenvima treat thyroid cancer? Lenvima patent expiration? Lenvima? Lenvima price? Lenvima 4mg price? Lenvima fda approval date?