Catalyst Wire Dossier Catalyst Wire Dossier
EMA approval · 2025-06-10

EMA Authorised: Rozlytrek (Entrectinib) — Roche Registration GmbH

View source ↗

Summary

The EMA authorised Rozlytrek (entrectinib) for cancer with a conditional approval, including non-small cell lung cancer. The marketing authorization holder is R…

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • Rozlytrek (entrectinib)

Snippet

Status: Authorised. Therapeutic area: Cancer;Carcinoma, Non-Small-Cell Lung. MAH: Roche Registration GmbH. Decision date: 24/03/2025. Conditional approval