Fig. 6.

Timeline of PARPi approvals by the EMA and FDA. Olaparib (Lynparza®) was the first PARPi to receive regular approval by both agencies in 2014 for ovarian cancer, followed by niraparib (Zejula®) in 2017. In 2018, olaparib’s indications expanded to breast cancer (FDA), while talazoparib (Talzenna®) and rucaparib (Rubraca®) received approvals for breast and ovarian cancer, respectively. Subsequent years saw a rapid expansion of indications: olaparib for pancreatic cancer (FDA, 2019; EMA, 2020) and the first approvals for metastatic castration-resistant prostate cancer (mCRPC) for both olaparib (FDA and EMA) and rucaparib (FDA) in 2020. Notably, the timeline reflects a recent shift toward combination therapies, including olaparib with bevacizumab for ovarian cancer (FDA and EMA, 2020) and multiple PARPi combinations with androgen receptor-signaling inhibitors (abiraterone, enzalutamide) for mCRPC (2022–2023). Most recently, in 2024, olaparib was approved in combination with durvalumab for endometrial cancer (EMA), highlighting the ongoing integration of PARPi into immuno-oncology regimens. Figure created with BioRender