Related Experiment Video

Updated: Jan 21, 2026

Generation of Recombinant Arenavirus for Vaccine Development in FDA-Approved Vero Cells
10:03

Generation of Recombinant Arenavirus for Vaccine Development in FDA-Approved Vero Cells

Published on: August 1, 2013

17.5K

Entrectinib: First Global Approval

Zaina T Al-Salama1, Susan J Keam2

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|August 3, 2019
PubMed

Insights

Entrectinib, a targeted cancer therapy, has gained its first global approval in Japan for NTRK fusion-positive solid tumors. This milestone marks a significant advancement in treating specific advanced or recurrent cancers.

Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • Entrectinib is an oral tyrosine kinase inhibitor targeting tropomyosin receptor kinases (Trk)A/B/C, ROS1, and ALK.
  • These targets are implicated in various solid tumors through gene fusions (NTRK1/2/3 or ROS1).
  • Entrectinib possesses central nervous system (CNS) activity, crucial for treating brain metastases.

Purpose of the Study:

  • To summarize the developmental milestones of entrectinib.
  • To highlight the drug's first global approval for solid tumors in Japan.

Main Methods:

  • Review of preclinical and clinical development data.
  • Analysis of regulatory submission and approval processes.

Main Results:

  • Entrectinib received its first global approval in Japan in June 2019.
  • The approval is for adult and pediatric patients with NTRK fusion-positive, advanced or recurrent solid tumors.
  • Regulatory reviews are ongoing in the USA and EU for NTRK-positive solid tumors and ROS1-positive non-small cell lung cancer (NSCLC).

Conclusions:

  • Entrectinib's development journey has culminated in its first global approval, offering a new therapeutic option.
  • The drug's targeted nature and CNS activity represent significant progress in precision oncology.
  • Further regulatory approvals are anticipated, potentially expanding treatment access globally.

More Related Videos

The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression10:29

The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression

Published on: November 12, 2010

40.5K
Measuring Near Plasma Membrane and Global Intracellular Calcium Dynamics in Astrocytes12:48

Measuring Near Plasma Membrane and Global Intracellular Calcium Dynamics in Astrocytes

Published on: April 26, 2009

13.5K

Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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,...
246
Global Climate Change01:50

Global Climate Change

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.
28.7K
Introduction to Global Positioning System01:30

Introduction to Global Positioning System

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,...
480
Global Regulatory Systems01:28

Global Regulatory Systems

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...
623
Errors in Global Positioning System01:26

Errors in Global Positioning System

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,...
345
Field Application of Global Positioning System01:28

Field Application of Global Positioning System

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...
327