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Updated: Feb 7, 2026

Analysis of Lymph Node Volume by Ultra-High-Frequency Ultrasound Imaging in the Braf/Pten Genetically Engineered Mouse Model of Melanoma
Published on: September 8, 2021
Abstract:
The FDA approved the BRAF/MEK inhibitor combination encorafenib/binimetinib for patients with metastatic or inoperable melanoma with a BRAF V600E or V600K mutation. The approval was based on results of a phase III trial in which patients treated with the combination had a median progression-free survival of 14.9 months, compared with 7.3 months in a control group that received vemurafenib alone.
Insights
The FDA approved encorafenib/binimetinib for BRAF-mutant melanoma. This combination therapy significantly improved progression-free survival compared to vemurafenib alone in a Phase III trial.
Area of Science:
- Oncology
- Pharmacology
Background:
- The U.S. Food and Drug Administration (FDA) has approved the combination therapy of encorafenib and binimetinib for patients diagnosed with metastatic or inoperable melanoma.
- This approval specifically targets patients harboring the BRAF V600E or V600K mutation, a common genetic driver in melanoma.
Discussion:
- The FDA's decision was informed by pivotal Phase III clinical trial data.
- The trial demonstrated a substantial improvement in median progression-free survival for patients receiving the encorafenib/binimetinib combination.
Key Insights:
- Median progression-free survival was 14.9 months for the combination arm.
- The control group, treated with vemurafenib monotherapy, achieved a median progression-free survival of 7.3 months.
- This represents a doubling of progression-free survival, highlighting the efficacy of the combination therapy.
Outlook:
- This approval offers a new, more effective treatment option for patients with BRAF-mutant melanoma.
- Further research may explore long-term survival benefits and potential resistance mechanisms.
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