Friday, July 10, 2026

Drug profile · INN

entrectinib

entrectinib (ROZLYTREK) is a neurotrophic tyrosine kinase receptor inhibitor. Associated with Hoffmann-La Roche. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L01) L01EX14
US status approved
Patents linked 0
Pipeline programs 7
News articles 1
Drug details — entrectinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
7
Data quality
0.84

Quick answer

entrectinib (ROZLYTREK) is a neurotrophic tyrosine kinase receptor inhibitor. Associated with Hoffmann-La Roche. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN entrectinib
Brand ROZLYTREK
Mechanism Neurotrophic tyrosine kinase receptor inhibitor
Target ALK tyrosine kinase receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01EX14

Mechanism of action

Neurotrophic tyrosine kinase receptor inhibitor

Primary target: ALK tyrosine kinase receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Recent coverage

Pipeline programs

  1. BX44273 Phase 3 · HOFFMANN-LA ROCHE · This is an extension study designed to provide continued tre
  2. MO41552 Phase 3 · HOFFMANN-LA ROCHE · Non-small cell lung cancer with ROS proto-oncogene 1, recept
  3. BO41932 Phase 2 · HOFFMANN-LA ROCHE · Solid tumors
  4. CO40778 Phase 2 · HOFFMANN-LA ROCHE · Pediatric Solid tumors and primary central nervous system (C
  5. Entrectinib Phase 2 · HOFFMANN-LA ROCHE · Solid Tumors
  6. Entrectinib Phase 2 · HOFFMANN-LA ROCHE · Breast Cancer
  7. Rozlytrek 200 mg hard capsules Phase 2 · HOFFMANN-LA ROCHE · Locally Advanced or Metastatic Solid Tumors that Harbor NTRK

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is entrectinib?

entrectinib (ROZLYTREK) is a neurotrophic tyrosine kinase receptor inhibitor. Associated with Hoffmann-La Roche. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for entrectinib?

ROZLYTREK is a marketed brand name for entrectinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of entrectinib?

entrectinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.