Olaparib [OLAP10]

Olaparib as monotherapy for treatment of adults with deleterious or suspected deleterious germline BRCA1 or 2 mutations who have HER-2 negative locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane in the adjuvant/neoadjuvant/advanced disease settings and also treated with prior endocrine-based therapy if the patient has hormone-receptor positive disease where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with olaparib monotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. This patient has a proven histological diagnosis of HER 2 negative breast cancer.
3. The patient has locally advanced or metastatic breast cancer.
4. This patient HAS a documented germline deleterious or suspected deleterious BRCA 1 or BRCA 2 mutation(s). Please enter below as to which deleterious or suspected deleterious BRCA mutation(s) the patient has:

• BRCA 1 mutation or
• BRCA 2 mutation or
• both BRCA1 and BRCA 2 mutations

5. The patient has received prior chemotherapy with an anthracycline and a taxane in any of the adjuvant or neoadjuvant or advanced disease settings unless these chemotherapy agents were contraindicated Please enter below as to which of the following scenarios applies to this patient:

• the patient has received treatment with both an anthracycline and a taxane in any of the adjuvant or neoadjuvant or advanced disease settings or
• chemotherapy with an anthracycline was contraindicated in the adjuvant or neoadjuvant or advanced disease settings and the patient has received a taxane in one of these indications
• chemotherapy with a taxane was contraindicated in the adjuvant or neoadjuvant or advanced disease settings and the patient has received an anthracycline in one of these indications
• chemotherapy with both an anthracycline and a taxane were contraindicated in the adjuvant or neoadjuvant or advanced disease settings

6. The patient either has triple negative disease or if the patient has hormone receptor positive disease then the patient has already been treated with appropriate endocrine-based therapy or such therapy was contraindicated. Please mark below which option applies to this patient:

• the patient has triple negative disease or
• the patient has hormone receptor positive disease and received appropriate endocrine-based therapy or
• the patient has hormone receptor positive disease and use of appropriate endocrine-based therapy was contraindicated in this patient

7. Olaparib will be used as monotherapy and not in combination with any endocrine-based therapy
8. The patient has not received any previous treatment with a PARP inhibitor unless talazoparib for this same breast cancer indication has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression or the patient has received adjuvant olaparib and this was completed without disease progression during therapy or within 12 months of its completion or the patient has received olaparib via a company compassionate access scheme and all other treatment criteria in this form are fulfilled. Please mark below which option applies to this patient:

• the patient has never received any PARP inhibitor therapy or
• talazoparib for this same advanced breast cancer indication has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression or
• the patient has received adjuvant olaparib and this was completed without disease progression during therapy or within 12 months of its completion
• the patient has received olaparib for this indication via a company compassionate access scheme and all other treatment criteria in this form are fulfilled

9. The patient has an ECOG performance status of either 0 or 1.
10. Any brain metastases or leptomeningeal metastases in this patient are symptomatically stable.
11. Olaparib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment.
12. The prescribing clinician is aware of the dose reductions necessary for olaparib in patients with renal impairment as specified in the olaparib Summary of Product Characteristics (section 4.2).
13. The prescribing clinician is aware of the potential drug interactions which olaparib has with other medicines, as outlined in sections 4.2 and 4.5 of the olaparib Summary of Product Characteristics.
14. A formal medical review as to how olaparib is being tolerated and whether olaparib should continue or not will be scheduled to occur at least by the start of the third 4-weekly cycle of treatment.
15. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
16. Olaparib is to be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 09 January 2025

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