FDA Oncology Announcements

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21 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 adjuvant treatment of high-risk early breast cancer

Trial: OlympiA
Drug: Lynparza (olaparib) · PARP inhibitor
Condition: Breast

FDA approves olaparib for HRR gene-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

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

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

FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers

Trial: DUO-O
Drugs: LYNPARZA (olaparib) · PARP inhibitor, bevacizumab · Anti-VEGFR antibody
Condition: Gynecologic

FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers

Trial: DUO-O
Drugs: LYNPARZA (olaparib) · PARP inhibitor, bevacizumab · Anti-VEGFR antibody
Condition: Gynecologic

FDA approves niraparib for first-line maintenance of advanced ovarian cancer

Drug: ZEJULA (niraparib) · PARP inhibitor
Condition: Gynecologic

FDA approves niraparib for first-line maintenance of advanced ovarian cancer

Drug: ZEJULA (niraparib) · PARP inhibitor
Condition: Gynecologic

FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma

Trial: POLO
Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Gastrointestinal

FDA approves niraparib for HRD-positive advanced ovarian cancer

Trial: QUADRA
Drug: ZEJULA (niraparib) · PARP inhibitor
Condition: Gynecologic

FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based

Trial: SOLO-1
Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Gynecologic

FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer

Trial: EMBRACA
Drug: TALZENNA (talazoparib) · PARP inhibitor
Condition: Breast

FDA approves rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer

Trial: ARIEL3
Drug: Rubraca (rucaparib) · PARP inhibitor
Condition: Gynecologic

FDA approves olaparib for germline BRCA-mutated metastatic breast cancer

Trial: OlympiAD
Drug: Lynparza (olaparib) · PARP inhibitor
Condition: Breast

FDA approves olaparib tablets for maintenance treatment in ovarian cancer

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

Rucaparib

Drug: RUBRACA (rucaparib) · PARP inhibitor
Condition: Gynecologic

Olaparib

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