Drug updated on 12/11/2024
Dosage Form | Capsule (oral; 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg, 1 mg) |
Drug Class | Poly (ADP-ribose) polymerase (PARP) inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer
- Indicated in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Latest News
Summary
- This summary is based on the review of 16 systematic review(s)/meta-analysis(es). [1-16]
- Radiographic Progression-Free Survival (rPFS) and Overall Survival (OS): No significant difference in Event-Free Survival (EFS) or OS was observed between intermittent pegylated-asparaginase (PEG-asp) (eight doses) and continuous PEG-asp (15 doses) in non-high-risk acute lymphoblastic leukemia (ALL) patients, as well as between low-risk standard treatment with additional PEG-asp (six doses) and standard treatment (two doses), with risk ratios (RR) close to 1. In metastatic castration-resistant prostate cancer (mCRPC), olaparib demonstrated a significant improvement in rPFS with a hazard ratio (HR) of 0.67 (95% confidence interval (CI): 0.46-0.96) when compared to niraparib and talazoparib, while no significant differences were observed in OS among these treatments. Talazoparib plus enzalutamide had a lower probability of being the most effective for rPFS (13%) and OS (19%) compared to a nonstandard dose of docetaxel.
- Progression-Free Survival (PFS) and OS in BReast CAncer (BRCA)-Mutated Metastatic Breast Cancer (MBC): Both olaparib and talazoparib significantly improved PFS with HRs of 0.64 and 0.54, respectively, compared to standard chemotherapy; however, there were no significant differences in OS.
- Combination Therapies: polymerase (PARP) inhibitor (PARPi) and androgen receptor signaling inhibitor (ARSI) combinations improved rPFS (HR: 0.62) and OS (HR: 0.84) compared to ARSI alone in mCRPC.
- Objective Response Rate (ORR) in BRCA-Mutated HER2-Negative MBC: Both olaparib and talazoparib exhibited higher ORRs than standard chemotherapy, indicating greater efficacy in this population.
- Hematological Toxicities: Talazoparib significantly increased the risk of all grades and ≥G3 anemia, neutropenia, and thrombocytopenia compared to non-PARP inhibitors. It also presented a higher risk of treatment interruption and dose reduction due to adverse events compared to other PARP inhibitors.
- Adverse Events (AEs): Talazoparib had a higher incidence of grade ≥3 adverse events, with an odds ratio of 3.7 when compared to olaparib and niraparib. In contrast, olaparib and rucaparib did not significantly increase the incidence of grade ≥3 AEs.
- Serious AEs (SAEs) and Discontinuation: There were no significant differences in the occurrence of serious adverse events or discontinuation related to adverse events among olaparib, rucaparib, niraparib, and talazoparib.
- BRCA-Mutated Populations: There is significant efficacy of PARP inhibitors (PARPis), including talazoparib, in BRCA-positive patients with mCRPC and MBC, with additional evidence of efficacy for PARPi combined with ARSI in HRR-proficient mCRPC. Careful monitoring for increased hematological toxicities is recommended for patients using talazoparib, especially in those with mCRPC.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Talzenna (talazoparib) Prescribing Information. | 2024 | Pfizer Inc., New York, NY |