Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to rucaparib for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

This is written in the approval document as:

RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Citation

Clovis Oncology, Inc. Rubraca (rucaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209115s014s015lbl.pdf. Revised December 2025. Accessed December 23, 2025.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (1) BRCA1 oncogenic variants Ovarian Epithelial Tumor Rucaparib
FDA (1) BRCA1 pathogenic variants Ovarian Epithelial Tumor Rucaparib
FDA (1) BRCA2 oncogenic variants Ovarian Epithelial Tumor Rucaparib
FDA (1) BRCA2 pathogenic variants Ovarian Epithelial Tumor Rucaparib
FDA (1) BRCA1 oncogenic variants High-Grade Serous Fallopian Tube Cancer Rucaparib
FDA (1) BRCA1 pathogenic variants High-Grade Serous Fallopian Tube Cancer Rucaparib
FDA (1) BRCA2 oncogenic variants High-Grade Serous Fallopian Tube Cancer Rucaparib
FDA (1) BRCA2 pathogenic variants High-Grade Serous Fallopian Tube Cancer Rucaparib
FDA (1) BRCA1 oncogenic variants Peritoneal Serous Carcinoma Rucaparib
FDA (1) BRCA1 pathogenic variants Peritoneal Serous Carcinoma Rucaparib
FDA (1) BRCA2 oncogenic variants Peritoneal Serous Carcinoma Rucaparib
FDA (1) BRCA2 pathogenic variants Peritoneal Serous Carcinoma Rucaparib