OLAPARIB TAB
Clinical Criteria Summary
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Exclusion Criteria
- Creatinine clearance less than or equal to 30 mL/min
- Concomitant strong or moderate CYP3A inducers
- Concomitant strong or moderate CYP3A inhibitors (if unavoidable, reduce olaparib dose per labeling)
- Untreated or uncontrolled brain metastases
- Pregnancy (known pregnancy or positive pregnancy test)
- Breastfeeding
General Inclusion Criteria
- Care provided by a VA/VA purchased care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Goals of care and role of Palliative Care consult discussed and documented
- Male patients with partners of reproductive potential or who are pregnant must use effective contraception during treatment and for 3 months following the last dose
Additional Inclusion Criteria (Metastatic Castration-Resistant Prostate Cancer)
- Radiographic disease progression following treatment with enzalutamide or abiraterone/prednisone (prior docetaxel allowed)
- Mutation in Homologous Recombination Repair (HRR) gene confirmed by FDA-approved companion diagnostic
- Ongoing castration with prior surgical castration or concomitant LHRH analogue
Other Indications
- Provide evidence to support use
Additional Considerations
- For HRR gene mutations other than BRCA2, consider a clinical trial if available and patient is eligible
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Patient Population & Indication
- • Adult patients with metastatic castration-resistant prostate cancer (mCRPC)
- • Deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated
Prior Therapy Requirements
- • Disease must have progressed following prior treatment with enzalutamide or abiraterone
Diagnostic & Testing Requirements
- • Selection for therapy must be based on an FDA-approved companion diagnostic for olaparib
Additional VA-Specific Considerations
- • Patients with non-BRCA2 HRR mutations may consider a clinical trial if available and the patient is eligible