The EMA is Reviewing the Ovarian Cancer Drug Rucaparib After New Reports

Medscape recently published an article stating that the EMA is conducting a review of rucaparib, a drug used to treat patients with a range of ovarian cancers that have relapsed. These patients also have a BRCA mutation.

BRCA genes produce a protein that helps to repair damaged DNA. One copy is inherited from each parent. Cancer can develop when the BRACA genes have harmful changes (mutations).

The EMA’s initial findings were a shorter overall survival period when compared to chemotherapy patients who have related issues plus a BRCA mutation. The EMA has based its findings on an. interim-period discovery during the Phase III ARIEL 4 trial that is still in progress.

The EMA has asked that during the review period, although rucaparib may continue to be used for new patients with cancer of the ovaries, the agency cautions against using the drug on new patients who have a BRCA mutation, cancer of the fallopian tubes, ovaries, or peritoneum. This includes patients unable to tolerate a third platinum-based therapy.

Clovis Oncology, the developer of rucaparib, explained to Medscape Medical News that since most of rucaparib’s use applies to maintenance after chemotherapy, the EMA’s recommendations are not applicable. The maintenance setting does not affect the EMA’s review.

Clovis will issue a “Dear Doctor” letter throughout Europe to inform prescribers of the interim overall survival results of ARIEL4. Clovis is also working to fulfill its agreement with the agency to respond to its agreed-upon June 2022 timetable. The timetable includes a list of problems and questions.

About Rucaparib

Rucaparib is a PARP inhibitor approved in Europe in 2018. According to a recent article in Medscape, its mode of action is to prevent cancer cells from being repaired. This results in the death of the cancer cells.

In the UK and the EU, rucaparib is administered to adult patients who have cancer that has progressed or relapsed, are platinum-sensitive, and can no longer tolerate platinum-based chemotherapy after having received at least two prior lines. There is a distinction, however, that rucaparib has not been approved to treat platinum-resistant tumors.

Clinicians are advised that while the review is in progress, they should refrain from treating patients with rucaparib who have the following conditions:

  • BRCA mutations
  • epithelial ovarian cancer (tissue covering the outside of an ovary)
  • primary peritoneal cancer (cells lining the inside wall of the abdomen)
  • cancer in the lining of a fallopian tube

Rucaparib has very similar restrictions in the U.S. However, it is also approved in the U.S. for metastatic castration-resistant prostate cancer harboring harmful BRCA mutations.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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