The second indication of Rubraca has been approved as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy.
Rucaparib is an oral and small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in various tumor types such as ovarian, metastatic castration-resistant prostate and bladder cancers, as monotherapy and in combination with other anti-cancer agents.
The current approval was based on data from the phase 3 Ariel 3 clinical study, which showed rucaparib significantly improved progression-free survival (PFS) in all ovarian cancer patient populations assessed.
The Ariel 3 double-blind and placebo-controlled clinical study had recruited 564 women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy.
The company had randomized patients to secure rucaparib tablets 600mg twice daily or placebo.
According to the company, the Ariel 3 study reached its primary endpoint of extending investigator-assessed PFS against placebo in all patients treated and secondary endpoint of extending PFS as assessed by independent radiological review (IRR).
Clovis Oncology president and CEO Patrick Mahaffy said: “This EC authorization of rucaparib is an important step in ensuring that it is available to all women who may potentially benefit, regardless of their BRCA status.
“”We believe that access to maintenance treatment is extremely important for women with relapsed platinum-sensitive ovarian cancer, and we are pleased that rucaparib can now be an option for these women.”
In May 2018, Clovis received EC approval for Rubraca for the treatment of women with recurrent ovarian cancer.
Rubraca was approved as amonotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, who were treated with two or more prior lines of platinum-based chemotherapy and who are unable to tolerate further platinum-based chemotherapy.
Clovis has also commenced exploratory studies with Rucaparib in other tumor types. Clovis has worldwide rights for Rubraca. It is also an unlicensed medical product outside of the US and Europe.