CHMP recommends restricting third-line rucaparib use in BRCA+ ovarian cancer

The recommendation was made following the final analysis of the phase III ARIEL4 study (NCT02855944), in which rucaparib failed to elicit an improvement in median overall survival at 19.4 months, compared with 25.4 months for chemotherapy (HR, 1.31; 95% CI, 1.00-1.73; P = .0017). The analysis follows a prior announcement that the study met its primary end point of progression-free survival (PFS), showing a median of 7.4 months with rucaparib vs 5.7 months with chemotherapy (HR, 0.639; P = .0010). Notably, the recommendation does not affect the use of rucaparib as maintenance treatment for adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

Rucaparib received a conditional approval on May 24, 2018, with the understanding that the company provided additional data from the ARIEL4 study to confirm the safety and effectiveness of the medicine in the third-line treatment indication.

While the review was ongoing, the CHMP issued temporary recommendations to restrict the use of rucaparib as third-line treatment in new patients as an interim measure to protect public health. The recommendation was sent to the European Commission, which issued a temporary legally binding decision applicable in all EU Member States on May 4, 2022. Now that the CHMP has completed its evaluation of the final study data from ARIEL4 and has issued its final recommendation, the opinion will be forwarded to the European Commission, which will announce a legally binding decision for all EU Member States.