Clovis PARP inhibitor Rubraca gets EC approval for relapsed ovarian cancer

January 26, 2019 | Filed under: Pharma Regulatory News | Posted by: pharmanewsdaily Tags: European Commission, Oncology, Ovarian Cancer, Patrick J. Mahaffy, Rubraca, rucaparib

Rubraca EC approval : US biotech company Clovis Oncology has secured approval for an additional indication for its cancer drug Rubraca (rucaparib) in Europe – as maintenance treatment for adult women whose ovarian cancer has relapsed.

The approval from the European Commission (EC) is for the PARP inhibitor to be used as monotherapy for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who show complete or partial response to platinum-based chemotherapy.

In May 2018, Rubraca was approved by the EC as monotherapy treatment for women with recurrent ovarian cancer.

The latest Rubraca EC approval was driven by the results of the phase 3 ARIEL3 clinical trial, which showed rucaparib to have improved progression-free survival in all ovarian cancer patient populations to a significant extent.

Clovis Oncology Rubraca EC approval. Image courtesy of dream designs at FreeDigitalPhotos.net.

The ARIEL3 trial featured 564 patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer with complete or partial response to platinum-based chemotherapy. Patients were randomly grouped in a 2:1 ratio to be administered rucaparib tablets 600mg twice daily or placebo.

The late stage clinical trial achieved its primary endpoint by prolonging progression-free survival (PFS) compared to placebo in all patients, irrespective of BRCA status. The key secondary endpoint of extending PFS was also achieved.

Patrick J. Mahaffy – President and CEO of Clovis Oncology, commenting on Rubraca EC approval, 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.

“As the only PARP inhibitor that has shown further tumor shrinkage as well as prolonged progression-free survival in this maintenance setting, we believe Rubraca represents an important step forward for women with advanced ovarian cancer.”

Rucaparib is an oral, small molecule that inhibits the PARP1, PARP2 and PARP3 enzymes. It is being developed for various tumor forms such as ovarian, metastatic castration-resistant prostate, and bladder cancers, both as monotherapy, and as a combination therapy with other anti-cancer agents.

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