Approval of reimbursement for the indication: “as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of RUBRACA (rucaparib) 200 mg, 250 mg and 300 mg, film-coated tablets, is substantial in the marketing authorisation indication.
Clinical Added Value
minor
In view of:
the evidence of the superiority of rucaparib monotherapy versus placebo, in a randomised double-blind study, in terms of investigator-assessed progression-free survival:
HRD subpopulation: HR = 0.47; 95% CI [0.31-0.72]; p = 0.0005; with a median progression-free survival of 28.7 months of rucaparib + IV placebo group and 11.3 months in the oral placebo + IV placebo group;
ITT population: HR = 0.52; 95% CI [0.40-0.68]; p < 0.0001; with a median progression-free survival of 20.2 months of rucaparib + IV placebo group and 11.0 months in the oral placebo + IV placebo group;
the lack of evidence of superiority on overall survival in the HRD subpopulation and the ITT population in an interim analysis;
limited follow-up of the efficacy of rucaparib with a median follow-up of approximately 26 months;
the lack of formal conclusion that can be drawn from the quality-of-life findings;
the safety profile of rucaparib marked in particular by a high incidence of grade ≥ 3 (61% and 23%) adverse events (AEs), serious AEs (21% and 6%) and by the onset of myelodysplastic syndromes/acute myeloid leukaemia;
the context of the current strategy which includes one available treatment (olaparib/bevacizumab) with evidence of an improvement in overall survival as maintenance treatment for patients with a tumour positive for homologous recombination deficiency (HRD).
the Committee deems that, based on the data currently available,RUBRACA (rucaparib)200 mg, 250 mg and 300 mg, film-coated tablets, in the same way as ZEJULA (niraparib),provides minor clinical added value (CAV IV) for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
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