Is Sotorasib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Sotorasib, including Lumakras (120 mg, Tablet, SAR 37902.60).

Is Sotorasib approved by the US FDA?

Drugs@FDA lists 1 application product line for Sotorasib, including LUMAKRAS (Prescription).

Is Sotorasib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sotorasib: Lumykras.

Are there safety signals or safety updates for Sotorasib?

US FDA: 1 entry (latest 2025-01-16).

Active substance

Sotorasib

SFDA 1
US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Lumakras	120 mg	Tablet · Oral use	240 Bottle	SAR 37902.60	NCE · Prescription	Amgen Inc.	Valid

Indications — CHI Daman Drug Formulary

COLORECTAL CANCER-ADVANCED/ METASTATIC; NON-SMALL-CELL LUNG CARCINOMA (NSCLC)

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

Product	Strength	Form · route	Applicant	Status	First approved
LUMAKRAS	120MG; 320MG; 240MG	tablet · oral	AMGEN INC	Prescription	28 May 2021

EMA European Union — centrally authorised medicines

Lumykras Amgen Europe B.V. · Authorised · authorised 6 Jan 2022 · ATC L01XX73

Therapeutic indication (EMA)

Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LUMAKRAS	02520095	120 MG	TABLET · ORAL	AMGEN CANADA INC
LUMAKRAS	02552655	240 MG	TABLET · ORAL	AMGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 16 Jan 2025 LUMAKRAS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for sotorasib →

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.