Table 1 Approved indications for PARPi by FDA & NMPA (in order of approval time)
Drug | Approved Time | Application | Indication | Clinical Trials |
|---|---|---|---|---|
Olaparib | 2014.12 (FDA) | Late-line monotherapy | Adult patients with advanced recurrent HGSOCs with germline BRCA mutations, who have received three or more prior lines of chemotherapy | Study 42 |
Rucaparib | 2016.12 (FDA) | Late-line monotherapy | Adult patients with advanced recurrent EOCs with germline BRCA mutations, who have received two or more prior lines of chemotherapy | Study 10 & ARIEL2 |
Niraparib | 2017.3 (FDA) | Maintenance therapy | Adult patients with recurrent EOCs, who had either a complete or a partial response to platinum-based chemotherapy | NOVA |
Olaparib | 2017.8 (FDA) | Maintenance therapy | Adult patients with recurrent EOCs, who had either a complete or a partial response to platinum-based chemotherapy | Study 19 & SOLO-2 |
Rucaparib | 2018.4 (FDA) | Maintenance therapy | ARIEL3 | |
Olaparib | 2018.8 (NMPA) | Maintenance therapy | Study 19 & SOLO-2 | |
Olaparib | 2018.12 (FDA) | Maintenance therapy | Newly diagnosed adult EOC patients with BRCA mutations, who had either a complete or a partial response to first-line platinum-based chemotherapy (frontline maintenance therapy) | SOLO-1 |
Niraparib | 2019.10 (FDA) | Late-line monotherapy | Recurrent adult EOC after three or more prior lines of chemotherapy: who are BRCA mutated or HRD-positive and platinum sensitive | QUADRA |
Olaparib | 2019.12 (NMPA) | Maintenance therapy | Newly diagnosed adult EOC patients with BRCA mutations, who had either a complete or a partial response to first-line platinum-based chemotherapy (frontline maintenance therapy) | SOLO-1 |
Niraparib | 2019.12 (NMPA) | Maintenance therapy | Adult patients with recurrent EOCs, who had either a complete or a partial response to platinum-based chemotherapy | NOVA |