Talzenna™

Drug - Talzenna™ (talazoparib) [Pfizer Inc.]

June 2019

Therapeutic area - Oncology, Oral, Breast Cancer

Initial approval criteria

Patient must:

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

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

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