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DrugTalzenna™ (talazoparib) [Pfizer Inc.]

June 2019

Therapeutic area - Oncology, Oral, Breast Cancer

Initial approval criteria

Patient must:

  • Have a diagnosis that is listed in the FDA-approved label 


  • Be ≥ 18 years old AND
  • Have HER2-negative or deleterious or suspected-deleterious germline BRCA-mutated disease as detected by an FDA-approved test AND
  • Not have received prior therapy with a PARP-inhibitor AND
  • Not have untreated CNS metastases (i.e., patient has completed definitive local therapy and have stable CNS lesions on repeat brain imaging) AND
  • Not have experienced disease progression while receiving a platinum-based chemotherapy or relapsed within 6 months while receiving neoadjuvant or adjuvant platinum therapy AND

Talazoparib (Talzenna) will:

  • Be used as a single agent AND
  • Not be used in combination with any other poly ADP-ribose polymerase (PARP) inhibitors AND
  • Be used as subsequent treatment after prior chemotherapy in the neoadjuvant, adjuvant, locally advanced or metastatic treatment setting, which included a taxane and/or an anthracycline
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the criteria for initial approval AND
  • Tumor response has been demonstrated with either stabilization of disease or decrease in size of tumor or tumor spread AND
  • Absence of unacceptable toxicity from the drug AND
  • Patient has not developed myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)
  • Renewal approval is for 6 months

Quantity limits

  • 1 mg capsule:34 capsules/34 days
  • 0.25 mg capsule: 102 capsules/34 days


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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