Talazoparib (Talzenna®) – Mammary carcinoma, BRCA1/2 mutation, HER2-

1. Characteristics

Start date 01.06.2020
Resolution 20.11.2020
INN Talazoparib
Brand name Talzenna®
Company Pfizer Pharma GmbH
G-BA procedure ID 2020-06-01-D-545
ATC code L01XK04
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
DDD 1 mg O
Therapeutic area Oncological diseases
Reason for procedure New INN
Specialties Special practice conditions

Indication (German)

Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments.

Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

Subgroup Indication Comparator
Erwachsene Patienten mit HER2-negativem, lokal fortgeschrittenen oder metastasierten Mammakarzinom mit BRCA1/2-Mutationen in der Keimbahn; nach vorangegangener Therapie mit einem Anthrazyklin und/ oder einem Taxan im (neo)adjuvanten oder metastasierten Setting oder ungeeignet für diese Behandlungen − Capecitabin oder − Eribulin oder − Vinorelbin oder − eine Anthrazyklin- oder Taxan-haltige Therapie (Nur für Patienten, die noch keine Anthrazyklin- und Taxan-haltige Therapie erhalten haben oder für die eine erneute Anthrazyklin- oder Taxan-haltige Therapie infrage kommt.)

9. Associated procedures

Resolution INN Brand name Indication Additional benefit
Talazoparib Talzenna® Mammary carcinoma, BRCA1/2 mutation, HER2-

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