Rucaparib in ovarian cancer

Results from four pivotal clinical trials demonstrate that rucaparib is a well-tolerated monotherapy with anti-tumor activity in both the treatment and maintenance settings. Study10 is a Phase I/II trial designed to determine the recommended starting dose of rucaparib in patients with solid tumors and to evaluate the safety, efficacy, and pharmacokinetics of rucaparib in patients with BRCA-mutated ovarian cancer. ARIEL2 is a Phase II trial designed to evaluate the safety and efficacy of rucaparib in patients with high-grade ovarian cancer.

In an analysis of the combined efficacy of Study10 and ARIEL2 in patients with germline and/or somatic BRCA mutation-associated recurrent ovarian cancer who received two or more chemotherapy treatments, the investigator-assessed objective response rate ( ORR) was 53.8% (95% confidence interval [CI] 43.8–63.5), and investigator-assessed progression-free survival (PFS) was 10.0 months (range: 0.0–22.1; 95% CI, 7.3–12.5). The ORR confirmed by investigator assessment was 64.6% (95% confidence interval, 53.0–75.0), and the median PFS was 10.9 months (95% confidence interval, 8.4–12.8).

The original drug Rucapani has not yet been marketed in the country, so it has not entered the medical insurance coverage standards. The European version of rucapani original drug, specifications300mg*60 tablets sold overseas may cost more than 20,000 yuan per box (the price may fluctuate due to exchange rate effects), which is relatively expensive. There are also cheap generic rucapani drugs available overseas, and their pharmaceutical ingredients are basically the same as those of the original rucapani drug. For example, in India, the price of BDR pharmaceutical specifications of 300mg*60 tablets per box may be more than 6,000 yuan (the price may fluctuate due to exchange rate effects).