Is Tucatinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Tucatinib, including Tukysa (50 mg, Film-coated tablet, SAR 9638.40); Tukysa (150 mg, Film-coated tablet, SAR 27600.90).

Is Tucatinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Tucatinib, including TUKYSA (Prescription).

Is Tucatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tucatinib: Tukysa.

Active substance

Tucatinib

SFDA 2
US FDA 1
EMA 1
Health Canada 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Tukysa	50 mg	Film-coated tablet · Oral use	88 Blister	SAR 9638.40	NCE · Prescription	Pfizer Europe MA EEIG	Valid
Tukysa	150 mg	Film-coated tablet · Oral use	84 Blister	SAR 27600.90	NCE · Prescription	Pfizer Europe MA EEIG	Valid

Indications — CHI Daman Drug Formulary

BREAST CANCER HER-2 +VE; COLORECTAL CANCER-ADVANCED/ METASTATIC

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

Product	Strength	Form · route	Applicant	Status	First approved
TUKYSA	50MG; 150MG	tablet · oral	SEAGEN	Prescription	17 Apr 2020

EMA European Union — centrally authorised medicines

Tukysa Pfizer Europe MA EEIG · Authorised · authorised 11 Feb 2021 · ATC L01EH03

Therapeutic indication (EMA)

Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2?positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TUKYSA	02499827	50 MG	TABLET · ORAL	PFIZER CANADA ULC
TUKYSA	02499835	150 MG	TABLET · ORAL	PFIZER CANADA ULC

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.