GSK plc — Zejula EMA EPAR public assessment report (EMEA/H/C/004249, 2017)
GSK plc · 2017 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report details the assessment of Zejula (niraparib) for marketing authorization as a monotherapy for platinum-sensitive recurrent high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. It covers the regulatory process, orphan designation, and approved indication. The report outlines niraparib's quality control, non-clinical pharmacology (PARP-1/2 inhibition, BRCA-deficient cancer activity), and pharmacokinetic/pharmacodynamic profiles (absorption, distribution, metabolism, excretion). Toxicology studies identified bone marrow and testes as primary target organs. Efficacy and safety data from the pivotal NOVA trial are presented, demonstrating progression-free survival benefits and outlining common adverse events and dose modifications, ultimately supporting a positive benefit-risk profile.
Key findings — cited to the page
| Tumour regression rate in orthotopic high-grade serous ovarian cancer PDX models (all models) | 26 % | niraparib · p.22 |
| Tumour regression rate in orthotopic high-grade serous ovarian cancer PDX models (HRD positive models) | 44 % | niraparib · p.22 |
| Tumour shrinkage in BRCA-2mut high grade serous ovarian cancer PDX model | 36 % of baseline | niraparib · p.24 |
| Finished product dosage | 100 mg | niraparib · p.13 |
| EMA/CHMP eligibility agreement date | 25 June 2015 | Zejula · p.7 |
| Confirmation of class waiver for paediatric investigations | 01 April 2016 | niraparib · p.13 |
| Dose | 300 mg | Zejula · p.11 |
| Orphan medicinal product designation | EU/3/10/760 | Zejula · EU · p.7 |
| IC50 for hERG current inhibition | 10 µM | niraparib · p.25 |
| Approved indication | Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. | Zejula · p.11 |
| Oral bioavailability in rats | 27 % | niraparib · p.25 |
| Oral bioavailability in dogs | 57 % | niraparib · p.25 |
Source: GSK plc ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →