TALAZOPARIB CAP,ORAL
Clinical Criteria Summary
Document 665
Exclusion Criteria
- Absolute Neutrophil Count < 1500/µL
- Platelet count < 75,000/µL
- Hemoglobin < 9 g/dL (unless caused by bone marrow invasion)
- Unmanageable drug-drug interaction
- History of Myelodysplastic Syndrome or Acute Myeloid Leukemia
- Pregnancy
- Lactating
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 have been discussed and documented
Additional Inclusion Criteria
- Locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutation (gBRCAm)
- Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Homologous Recombination Repair (HRR) gene mutation, in combination with enzalutamide, for patients without prior novel androgen receptor inhibitor therapy in the mCRPC setting
Additional Inclusion Criteria if Applicable
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception during therapy and for 7 months after stopping treatment.
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Indications & Patient Population
- Breast cancer: Single agent for patients with deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced (LA) or metastatic breast cancer (MBC).
- Prostate cancer: In combination with enzalutamide for treatment of homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Dosing Regimen
- Breast cancer: 1 mg PO once daily.
- Prostate cancer: 0.5 mg PO once daily in combination with enzalutamide.
Formulary Status & Pathway Restrictions
- Breast cancer: Remains non-formulary due to Olaparib being the preferred PARP inhibitor on the VA Breast Cancer Pathway. Available via non-formulary processes for patients experiencing adherence issues with olaparib.
- Prostate cancer: Remains non-formulary as Olaparib is the preferred agent on the VA Oncology Prostate Cancer Pathway. Use in combination with enzalutamide may be adjudicated at the local level for off-pathway use.
Safety & Monitoring Considerations
- Boxed warnings: None.
- Warnings/Precautions: Myelodysplastic syndrome/Acute Myeloid Leukemia (MDS/AML), myelosuppression, embryo-fetal toxicity.
- Drug Interactions: Reduce dose with select P-gp inhibitors and monitor for adverse events. Monitor for increased adverse events with BRCP inhibitors.