Related Experiment Video
Updated: Feb 6, 2026
05:05
Labeling Stem Cells with Ferumoxytol, an FDA-Approved Iron Oxide Nanoparticle
Published on: November 4, 2011
21.6K
Encorafenib and Binimetinib: First Global Approvals
1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.
Drugs
|August 18, 2018
Summary
Encorafenib and binimetinib, targeting BRAF and MEK pathways respectively, are approved for advanced melanoma with specific mutations. This combination therapy offers a new treatment option for patients with BRAF-mutation-positive unresectable or metastatic melanoma.
Area of Science:
- Oncology
- Pharmacology
Background:
- Encorafenib is a BRAF inhibitor, and binimetinib is a MEK inhibitor.
- Both are orally bioavailable drugs developed by Array BioPharma.
Purpose of the Study:
- To summarize the development milestones of encorafenib and binimetinib.
- To highlight their first global approvals for treating specific melanoma types.
Main Methods:
- Review of drug development and regulatory submission data.
- Summary of clinical development phases and approvals.
Main Results:
- Encorafenib and binimetinib received US FDA approval in June 2018 for combination use.
- Applications submitted in EU, Australia, Switzerland, and Japan; positive opinion from EMA in July 2018.
- Combination therapy is also in Phase III trials for metastatic colorectal cancer.
Conclusions:
- Encorafenib and binimetinib combination therapy represents a significant advancement in treating BRAF-mutation-positive advanced melanoma.
- The development journey highlights successful targeted therapy drug discovery and approval processes.
Related Concept Videos
01:26FDA Approved Drugs: Changes to Approved Drugs
273
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
273
01:50Global Climate Change
29.0K
Throughout its ~4.5 billion year history, the Earth has experienced periods of warming and cooling. However, the current drastic increase in global temperatures is well outside of the Earth’s cyclic norms, and evidence for human-caused global climate change is compelling. Paleoclimatology, the study of ancient climate conditions, provides ample evidence for human-caused global climate change by comparing recent conditions with those in the past.
29.0K
01:30Introduction to Global Positioning System
541
The Global Positioning System (GPS) revolutionized positioning on Earth, providing precise location data through satellite ranging. The GPS system was developed in 1978 by the U.S. Department of Defense for military use, and it became available for civilian applications in 1983, transforming fields including navigation, fleet management, and time synchronization for telecommunications systems.GPS consists of satellites in medium Earth orbit, about 20,200 kilometers above the surface,...
541
01:26Errors in Global Positioning System
356
Global Positioning System (GPS) technology has revolutionized navigation and positioning, but its accuracy is often compromised by various errors. These errors, stemming from environmental, satellite, and receiver-related factors, require careful mitigation to ensure reliable performance across applications.Atmospheric ErrorsGPS signals travel through the Earth’s ionosphere and troposphere, introducing delays which affect accuracy. The ionosphere is strongly influenced by charged particles,...
356
01:28Global Regulatory Systems
692
Global regulatory systems in bacteria enable rapid and coordinated responses to environmental changes by integrating sensory inputs with gene expression, ensuring efficient adaptation to fluctuating conditions. Key global regulatory mechanisms include regulons, two-component systems, sigma factors, and secondary messengers.Regulons and Global RegulatorsA regulon is a collection of genes and operons controlled by a common global regulator. These regulators enable bacteria to prioritize resource...
692
01:28Field Application of Global Positioning System
332
The Global Positioning System (GPS) has become an indispensable tool in fieldwork, offering unparalleled precision and efficiency for surveying, navigation, and infrastructure development. By harnessing signals from a constellation of satellites, GPS receivers determine the location of objects with remarkable speed and accuracy, often completing calculations within a second.Advantages of Modern GPS TechnologyContemporary GPS receivers are designed to meet the practical demands of field...
332