Talzenna Adverse Reactions

Summary of the safety profile: The overall safety profile of Talzenna is based on pooled data from 494 patients who received talazoparib at 1 mg daily in clinical studies for solid tumours, including 286 patients from a randomised Phase 3 study with germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer and 83 patients from a nonrandomised Phase 2 study in patients with germline BRCA-mutated locally advanced or metastatic breast cancer.
The most common (≥25%) adverse reactions in patients receiving talazoparib in these clinical studies were fatigue (57.1%), anaemia (49.6%), nausea (44.3%), neutropenia (30.2%), thrombocytopenia (29.6%), and headache (26.5%). The most common (≥10%) Grade ≥3 adverse reactions of talazoparib were anaemia (35.2%), neutropenia (17.4%), and thrombocytopenia (16.8%).
Dose modifications (dose reductions or dose interruptions) due to any adverse reaction occurred in 62.3% of patients receiving Talzenna. The most common adverse reactions leading to dose modifications were anaemia (33.0%), neutropenia (15.8%), and thrombocytopenia (13.4%).
Permanent discontinuation due to an adverse reaction occurred in 3.6% of patients receiving Talzenna. The median duration of exposure was 5.4 months (range 0.03-61.1).
Tabulated list of adverse reactions: Table 5 summarises adverse reactions based on pooled dataset listed by system organ class, and frequency category. Frequency categories are defined as: very common (≥1/10) and common (≥1/100 to <1/10). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 5.)

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Description of selected adverse reactions: Myelosuppression: Myelosuppression-related adverse reactions of anaemia, neutropenia, and thrombocytopenia were very commonly reported in patients treated with talazoparib 1 mg/day. Grade 3 and Grade 4 myelosuppression-related events were reported for anaemia 34.8% and 0.4%, neutropenia 15.6% and 1.8%, and thrombocytopenia 12.8% and 4.0%. No deaths were reported due to myelosuppression-related adverse reactions. Myelosuppression-related adverse events associated with dose modifications were reported for up to approximately 30% of patients in the talazoparib 1 mg/day population and those associated with permanent study drug discontinuation were reported for less than 1% of patients.