EC approves first-line ovarian cancer treatment

24 November 2023

Catherine Eckford / European Pharmaceutical Review

A Phase III trial evaluating rucaparib demonstrated that it significantly improved progression-free survival in women with advanced ovarian cancer, regardless of their BRCA mutation status.

The European Commission (EC) has authorised a Type II variation for the poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca® (rucaparib). The small molecule treatment is indicated as a first-line maintenance treatment for individuals with advanced ovarian cancer regardless of their BRCA mutation status, who have responded to first-line platinum-based chemotherapy.

Prior to this new approval, rucaparib was previously 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.

Rucaparib: a first line treatment for advanced ovarian cancer

Frank Rotmann, Founder and Managing Director, pharma& explained that the EC’s approval will ensure that “…regardless of their BRCA mutation status [eligible patients] will have access to and may benefit from rucaparib earlier in their treatment journey.”

The EC based its approval the Phase III ATHENA-MONO study results. Rucaparib was found to significantly improved progression-free survival (PFS) compared with placebo in women, regardless of their BRCA mutation status. The Phase III ATHENA trial enrolled approximately 1,000 patients. The ATHENA-MONO study is evaluating the benefit of rucaparib monotherapy versus placebo in 538 women in this patient population.

The safety profile for rucaparib observed in the clinical trial was consistent with current US and European labels for rucaparib.

European Patients with this disease “need and deserve new treatment options to improve outcomes, according to Dr Rebecca Kristeleit, Consultant Medical Oncologist and Adjunct Reader, Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, London, UK, and European Network of Gynaecological Oncological Trial (ENGOT) lead of the ATHENA trial for rucaparib.

Since most patients have an initial response to the treatment, 80 percent will experience recurrence and require subsequent therapies, according to a 2012 paper published in Annals of Oncology. A paper published in the International Journal of Gynaecological Cancer reported that advanced ovarian cancer is still considered incurable for most patients, and the optimal treatment strategy has yet to be determined. Therefore, the EC’s decision offers these patients “hopeful news”, Dr Kristeleit added.



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