Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to niraparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Niraparib's product label states to select patients for therapy based on an FDA-approved companion diagnostic for niraparib.
This is written in the approval document as:
ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.
Citation
GlaxoSmithKline. Zejula (niraparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214876s000lbl.pdf. Revised April 2023. Accessed October 30, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BRCA1 pathogenic variants | Ovarian Epithelial Tumor | Niraparib | |
| Sensitivity (+) | BRCA2 pathogenic variants | Ovarian Epithelial Tumor | Niraparib | |
| Sensitivity (+) | BRCA1 pathogenic variants | High-Grade Serous Fallopian Tube Cancer | Niraparib | |
| Sensitivity (+) | BRCA2 pathogenic variants | High-Grade Serous Fallopian Tube Cancer | Niraparib | |
| Sensitivity (+) | BRCA1 pathogenic variants | Peritoneal Serous Carcinoma | Niraparib | |
| Sensitivity (+) | BRCA2 pathogenic variants | Peritoneal Serous Carcinoma | Niraparib |