Clovis Oncology, Inc. has announced that they have submitted an application to the European Medicines Agency (EMA). The application is to extend the drug Rubraca’s®(rucaparib) marketing authorisation to include maintenance treatment of adult patients who have certain forms of ovarian cancer and are in a partial or complete response to platinum based chemotherapy. The application has been validated by the EMA, who will now review it. Clovis is expecting to hear more updates on the application’s progression by the end of 2018. This information is based on a source article, which can be found here, at Business Wire.
About Rubraca® (Rucaparib)
Rubraca is a drug that is licensed to be used as a treatment for some forms of ovarian cancer. Amongst other requirements, the patients currently need to have been previously treated with at least two lines of platinum chemotherapy and be unable to undergo that treatment again. The recent application to the EMA, if successful, would broaden the drug’s current usage.
Rucaparib is an oral medicine that works by inhibiting the proteins PARP1, 2, and 3. These proteins are involved in many processes, including repairing DNA, which is a process linked to tumour formation.
The drug is currently being investigated for its use as a treatment for many other types of tumour, including certain prostate cancers, bladder cancers, and others.
Evidence Supporting the Application
The recent application is based on positive results from a recent Phase 3 clinical trial (ARIEL3) of rucaparib in patients with high-grade (more likely to grow and spread comparatively quickly) epithelial ovarian, fallopian tube, or primary peritoneal cancer. In total, 564 patients enrolled in the study. The patients were randomly assigned to either a group that was given 600mg of rucaparib twice per day or a group given a placebo.
The study investigated whether rucaparib was effective as a maintenance treatment for patients with platinum-sensitive ovarian cancer, which would prolong the period of disease control following chemotherapy.
It was found that rucaparib was linked to longer progression-free survival in patients compared to the placebo, and this was true for all BRCA statuses. The safety profile of the drug was also similar to what had been found in previous studies.
For more detailed information, visit Clovis Oncology’s website here.