FDA Oncology Announcements

PARP inhibitor × Genitourinary × Clear all

5 Announcements

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

Trial: TRITON3
Drug: Rubraca (rucaparib) · PARP inhibitor
Condition: Genitourinary

FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer

Trial: TALAPRO-2
Drugs: Talzenna (talazoparib) · PARP inhibitor, enzalutamide · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer

Drug: Lynparza (olaparib) · PARP inhibitor
Condition: Genitourinary

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Genitourinary

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

Trial: TRITON2
Drug: RUBRACA (rucaparib) · PARP inhibitor
Condition: Genitourinary