Is Pralsetinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Pralsetinib, including GAVRETO (Prescription); GAVRETO (Prescription).

Is Pralsetinib authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Pralsetinib.

Are there safety signals or safety updates for Pralsetinib?

US FDA: 1 entry (latest 2025-12-22).

Active substance

Pralsetinib

US FDA 2
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
GAVRETO	100MG	capsule · oral	RIGEL PHARMS	Prescription	4 Sep 2020
GAVRETO	100MG	capsule · oral	BLUEPRINT MEDICINES	Prescription	1 Dec 2020

EMA European Union — centrally authorised medicines

Gavreto Blueprint Medicines (Netherlands) B.V. · Withdrawn · authorised 18 Nov 2021 · ATC L01EX23

Therapeutic indication (EMA)

Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Safety signals and safety-related labeling changes

US FDA 22 Dec 2025 GAVRETO — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pralsetinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.