Abstract
In up to half of all ovarian cancers, homologous recombination deficiency, which is often caused by BRCA1 or BRCA2 gene mutation, plays an important role in the tumour development and progress. Tumours with a deficiency of homologous recombination is more sensitive to the blockade of repair of single-strand breaks by PARP inhibitors.
Niraparib is an orally administered inhibitor of PARP-1 and PARP-2 and the first PARP inhibitor to show efficacy in a patients without a germinal or somatic mutation in the BRCA1/2 genes, as well as in tumours that do not have a homologous recombination deficiency. Niraparib has been evaluated in phase III clinical trials PRIMA and NOVA, in which its efficacy and safety as monotherapy were tested in the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal carcinoma (FIGO stages III and IV) having objective response after completion of first-line platinum-based chemotherapy (PRIMA) and in the maintenance treatment of adult patients with recurrent and platinum sensitive high-grade serous ovarian, fallopian tube or primary peritoneal carcinoma with objective response after platinum-based chemotherapy (NOVA).
These trials demonstrated high efficacy and safety of niraparib and led to the registration of niraparib in these indications.