2022-07-25| Trials & Approvals

EMA Recommends Restriction on Rubraca

by Max Heirich
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the discontinuation of the drug Rubraca (rucaparib camsylate) to treat cancers of the ovary and fallopian tubes. This recommendation comes after the review of the data found in the ARIEL4 study, a study which compared the use of Rubraca as an alternative treatment to chemotherapy.


What Is Rubraca and What Does It Treat?


Rubraca is a PARP inhibitor used as an anti-cancer agent; it prevents cancer cells from being able to repair, thus killing them. The treatment has been authorized for use specifically for cancers of the ovaries, fallopian tubes, and the peritoneum. The patients who were eligible for Rubraca were those whose cancer has come back after at least two platinum-based chemotherapies and who cannot have further platinum-based therapy. 

Additionally, Rubraca can be a maintenance treatment for patients with recurrent cancer after they have completed a round of chemotherapy treatment. 

On the 24th of May, 2018, Rubraca received ‘conditional approval’ for its use as a third-line treatment. One of these conditions was that the drug had to prove its efficacy through data gained from the ARIEL4 study.

Related article: Cancer Research UK and Sosei Heptares Set for First Human Trial of EP4 Antagonist


ARIEL4 Study Proves Rubraca to Be Ineffective


The purpose of the ARIEL4 study is to compare the longevity of patients who had taken Rubraca as opposed to those who treated their cancer with further chemotherapy. The group tested were those whose cancer had already come back twice and were still eligible to receive further chemotherapy treatments. 

EMA announced that patients who took Rubraca lived an average of 19.4 months; this is in contrast to patients who continued to undergo chemotherapy treatments, who lived 25.4 months on average. As a result of this higher rate of mortality, Rubraca is no longer recommended for use as a third-line treatment for patients with cancer of the ovary, fallopian tubes or peritoneum with a BRCA mutation (genetic defect). 

Despite this Phase 3 trial proving Rubraca’s ineffectiveness as a treatment for these cancers, this recommendation will not affect its use as a maintenance treatment after a patient has gone through chemotherapy. 

Following the results found by the ARIEL4 study, the EMA no longer recommends the use of Rubraca for third-line treatment as it might be associated with a higher risk of death. Doctors for patients suffering from these specific cancers will begin to recommend alternative treatment plans going forward.


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