TALZENNA 1 Indications

talazoparib

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TALZENNA (talazoparib) is indicated as: 
a monotherapy for the treatment of adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced (not amenable to curative radiation or surgery) or metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, unless patients were inappropriate for these treatments.

1.1 Pediatrics

Pediatrics (<18 years of age): The safety and efficacy of TALZENNA in children and adolescents <18 years of age have not been established. Therefore, Health Canada has not authorized an indication for pediatric use.

1.2 Geriatrics

Geriatrics (≥65 years of age): Of the 494 patients who received TALZENNA, 85 patients were ≥65 years of age. No overall differences in safety or effectiveness of TALZENNA were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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1 Indications

TALZENNA (talazoparib) is indicated as: 
a monotherapy for the treatment of adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced (not amenable to curative radiation or surgery) or metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, unless patients were inappropriate for these treatments.

1.1 Pediatrics

Pediatrics (<18 years of age): The safety and efficacy of TALZENNA in children and adolescents <18 years of age have not been established. Therefore, Health Canada has not authorized an indication for pediatric use.

1.2 Geriatrics

Geriatrics (≥65 years of age): Of the 494 patients who received TALZENNA, 85 patients were ≥65 years of age. No overall differences in safety or effectiveness of TALZENNA were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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