Greater Glasgow and Clyde Medicines

Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for the following indications:

• Ovarian Cancers: 
  • Monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. 
  • Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA 1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. 
  • Monotherapy maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
  • In combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

• Breast cancer:
  • As monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have human epidermal growth factor receptor 2 (HER2)-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

• Prostate Cancer:
  • Monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
  • In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Prescribing Notes:

Non-formulary indications:

• Monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen is not recommended by SMC.
• 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 previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments is not recommended by SMC.

BNF Link