The National Institute of Health and Care Excellence (NICE) has recommended pharmaand’s (pharma&) Rubraca (rucaparib) as a first-line maintenance treatment option for a subset of advanced ovarian cancer patients.
The health technology assessment agency has recommended in final draft guidance that the drug be used on the NHS in England, Wales and Northern Ireland to treat advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults who have had a complete or partial response to first-line platinum-based chemotherapy.
Eligible patients must also be without a BRCA mutation and have homologous recombination deficiency (HRD) positive or negative disease, as well as not be able to receive bevacizumab.
NICE’s decision follows an approval from the Medicines and Healthcare products Regulatory Agency in January 2024 and is supported by positive results from the late-stage ATHENA trial.
In the ATHENA-MONO arm of the study, Rubraca monotherapy significantly improved investigator-assessed progression-free survival as a first-line maintenance treatment compared to placebo.
The safety profile observed in the ATHENAMONO arm was also consistent with both the current US and European licenses for Rubraca.
Ovarian cancer is the sixth most common cause of cancer-related death among women in the UK, with an estimated 7,500 new cases of the disease diagnosed between 2017 and 2019.
Despite recent advances in newly diagnosed ovarian cancer, advanced cases of the disease are still considered incurable for the majority of patients.
Rubraca belongs to a class of drugs called PARP inhibitors, which are designed to block the actions of proteins that help repair damaged cancer cells.
Frank Rotmann, founder and managing director, pharma&, said: “[This] decision marks a significant step forward for women with advanced ovarian cancer in England, Wales and Northern Ireland.
“We are committed to ensuring that all eligible patients are able to access and to potentially benefit from [Rubraca].”
pharma& acquired Rubraca from Clovis Oncology in 2023 as part of an auction associated with Clovis’ bankruptcy proceedings. The company paid $70m upfront for the rights to the drug, according to a regulatory filing at the time, which also outlined that the company could pay another $65m if certain regulatory and sales milestones are met.