老挝大熊 BIGBEAR OLADX 奥拉帕尼 Olaparib 150mg

• Maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients should be selected for therapy based on an FDA-approved companion diagnostic for olaparib.
• Maintenance treatment in combination with bevacizumab for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:
  • Deleterious or suspected deleterious BRCA mutation, and/or
  • Genomic instability.
    Patients should be selected for therapy based on an FDA-approved companion diagnostic for olaparib.
• Maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Patients should be selected for therapy based on an FDA-approved companion diagnostic for olaparib.

Breast Cancer

• Adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients should be selected for therapy based on an FDA-approved companion diagnostic for olaparib.
• Treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with endocrine therapy or be considered inappropriate for endocrine therapy. Patients should be selected for therapy based on an FDA-approved companion diagnostic for olaparib.

Pancreatic Cancer

• Maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Patients should be selected for therapy based on an FDA-approved companion diagnostic for olaparib.

Prostate Cancer

• Treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients should be selected for therapy based on an FDA-approved companion diagnostic for olaparib.
• In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for olaparib.

Dosage and Administration

• The recommended dose is 300 mg taken orally twice daily, with or without food. Refer to the full prescribing information for the recommended duration of treatment.
• Patients with mCRPC receiving olaparib should also receive a gonadotropin-releasing hormone (GnRH) analogue concurrently or should have had bilateral orchiectomy.
• For patients with moderate renal impairment (CLcr 31–50 mL/min), reduce the olaparib dose to 200 mg orally twice daily.