Table 1.
US Food and Drug Administration labels for different PARPi.
| PARP Inhibitor | Olaparib (Lynparza)–AstraZeneca | Rucaparib (Rubraca)—Clovis Oncology | Niraparib (Zejula)—GSK | Talazoparib (Talzenna)—Pfizer | |
|---|---|---|---|---|---|
| Cancer type | Monotherapy | Combination | Monotherapy | Monotherapy | Monotherapy |
| Ovarian | Treatment setting—patients with recurrent gBRCAm advanced cancer who have been treated with 3L+ of chemotherapy Maintenance setting—patients in CR or PR to platinum-based chemotherapy (recurrent disease) and germline or somatic BRCAm advanced cancer (1L) |
Maintenance setting—with bevacizumab (VEGFi) in patients in CR or PR to platinum-based chemotherapy and HRD-positive status | Treatment setting—patients with BRCAm (germline and/or somatic) cancer who have been treated with 2L+ of chemotherapies Maintenance setting—patients with recurrent cancer who are in a CR or PR to platinum-based chemotherapy |
Treatment setting—patients with advanced cancer who have been treated with 3L+ of chemotherapy and whose cancer is associated with HRD Maintenance setting—patients with advanced cancer who are in a CR or PR to 1L+ platinum-based chemotherapy |
N/A |
| Breast | Treatment setting—patients with gBRCAm, HER2-negative mBC who have been treated with chemotherapy | None | N/A | N/A | Treatment setting—patients with gBRCAm, HER2-negative locally advanced or mBC |
| Pancreatic | Maintenance setting—patients with gBRCAm mPA whose disease has not progressed on at least 16 weeks of 1L platinum-based chemotherapy | None | N/A | N/A | N/A |
| Prostate | Treatment setting—patients with germline or somatic HRR gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone | None | Treatment setting—patients with BRCAm (germline and/or somatic)-associated mCRPC who have been treated with androgen receptor therapy and a taxane-based chemotherapy | N/A | N/A |
Full label documents can be accessed here: Lynparza: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s014lbl.pdf (accessed on 4 October 2021); Zejula: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s015s017lbledt.pdf (accessed on 4 October 2021); Rubraca: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s004lbl.pdf (accessed on 4 October 2021); Talzenna: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf (accessed on 4 October 2021). Abbreviations used: gBRCAm: deleterious or potentially deleterious germline mutation in the BRCA1 or BRCA2 gene; 1L, 2L+, 3L+: first-line, second-line or more, and third-line or more of any given treatment; CR: complete response; PR: partial response; mBC: metastatic breast cancer; mPA: metastatic pancreatic adenocarcinoma; HRR: homologous recombination repair; mCRPC: metastatic, castration-resistant prostate cancer; VEGFi: inhibitor of vascular endothelial growth factor; HRD: homologous recombination deficient; N/A: not approved.