FDA Oncology Announcements

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17 Announcements

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

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

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

FDA approves olaparib for adjuvant treatment of high-risk early breast cancer

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

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

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

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

FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma

FDA approves niraparib for HRD-positive advanced ovarian cancer

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

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

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

FDA approves olaparib for germline BRCA-mutated metastatic breast cancer

FDA approves olaparib tablets for maintenance treatment in ovarian cancer

Rucaparib

Olaparib