Rucaparib has been given a positive opinion as a first-line maintenance treatment for patients with advanced ovarian cancer by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), its manufacturer Pharma& has announced.
Suitable for all women with advanced ovarian cancer, regardless of BRCA mutation status, who have responded to first-line platinum-based chemotherapy, rucaparib (brand name Rubraca) is a poly-ADP ribose polymerase (PARP) inhibitor.
The targeted cancer drug is currently approved as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.
The recent recommended approval from the CHMP is a Type II variation on the current license and is based on the randomised, double-blind, placebo-controlled, phase 3 ATHENA-MONO trial results.
The trial demonstrated that rucaparib significantly improved investigator-assessed progression-free survival compared with placebo in women, regardless of their BRCA mutation status in each of the populations studied.
The safety profile observed in the ATHENA-MONO trial was consistent with both the current US and European labels for rucaparib.
Dr Rebecca Kristeleit, consultant medical oncologist and adjunct reader at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, and European Network of Gynaecological Oncological Trial (ENGOT) lead of the ATHENA trial, said: ‘In the ATHENA-MONO trial, rucaparib prolonged progression-free survival, irrespective of molecular characteristics, and its potential approval by the European Medicines Agency as a first-line maintenance treatment is an important step forward in this difficult-to-treat population.
‘Women with advanced ovarian cancer need and deserve new treatment options to improve outcomes, and [this] recommendation is hopeful news for eligible patients in Europe.’
The European Commission will now review the positive opinion and Pharma& anticipates an approval decision in the coming months.
Elmar Zagler, founder and managing director, Pharma&, said: ‘Accessing effective medicines is the primary goal for both healthcare providers and patients, and it can be devastating when these medicines are no longer available.
‘Over the last five years, Pharma& has established itself as an agile, fully integrated global company that aspires to breathe new life into proven medicines like rucaparib.’
Earlier this year, rucaparib was found to improve progression-free survival in metastatic, castration-resistant prostate cancer with BRAC alteration compared to usual care.