Tucatinib (Tukysa®) – Mammary carcinoma, HER2+, at least 2 previous therapies, combination with trastuzumab and capecitabine

1. Characteristics

Start date 15.03.2021
Resolution 02.09.2021
INN Tucatinib
Brand name Tukysa®
Company Seagen Germany GmbH
G-BA procedure ID 2021-03-15-D-654
ATC code L01EH03
ICD-10 codes C50.0Malignant neoplasm of nipple and areola, C50.1Malignant neoplasm of central portion of breast, C50.2Malignant neoplasm of upper-inner quadrant of breast, C50.3Malignant neoplasm of lower-inner quadrant of breast, C50.4Malignant neoplasm of upper-outer quadrant of breast, C50.5Malignant neoplasm of lower-outer quadrant of breast, C50.6Malignant neoplasm of axillary tail of breast, C50.8Malignant neoplasm of overlapping sites of breast, C50.9Malignant neoplasm of breast of unspecified site
Therapeutic area Oncological diseases
Reason for procedure New INN
Specialties ACT change

Indication (German)

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.

Subgroup Indication Comparator
Erwachsene Patienten mit HER2-positivem, lokal fortgeschrittenem oder metastasiertem Brustkrebs, die zuvor mindestens zwei HER2-gerichtete Therapieregime erhalten haben Therapie nach ärztlicher Maßgabe. Im Rahmen der Therapie nach ärztlicher Maßgabe stellen die Behandlungsoptionen Lapatinib in Kombination mit Capecitabin, Lapatinib in Kombination mit Trastuzumab (nur für Patienten mit HR-negativem Mammakarzinom) und Trastuzumab in Kombination mit Capecitabin geeignete Komparatoren dar. Die Arzneimitteltherapie mit Trastuzumab in Kombination mit Capecitabin ist jedoch im vorliegenden Anwendungsgebiet nicht zugelassen

9. Associated procedures

Resolution INN Brand name Indication Additional benefit
Tucatinib Tukysa® Mammary carcinoma, HER2+, at least 2 previous therapies, combination with trastuzumab and capecitabine


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