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EMA's CHMP Recommends Restricting Third-Line Ovarian Cancer Indication for Clovis' Rubraca

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended that Clovis Oncology's PARP inhibitor Rubraca (rucaparib) no longer be used as a third-line treatment for BRCA1/2-mutated ovarian, fallopian tube, or primary peritoneal cancer.

The committee, determining that Rubraca is not as effective as chemotherapy in this treatment setting, said that doctors in the EU should not start any new patients on Rubraca in this setting. They should also make patients on Rubraca aware of the recommendation and suggest other options, the committee members advised.

The European Commission will now review CHMP's recommendation and decide whether to commence a legally binding withdrawal for the drug for this indication.

In 2018, the EC granted a conditional authorization for the drug in this patient population, making it available across the EU contingent on confirmatory studies. Now, results from the Phase III ARIEL4 trial, which pitted Rubraca against chemotherapy as a third-line treatment in BRCA1/2-mutated ovarian, fallopian tube, and primary peritoneal cancer patients, have shown that Clovis' PARP inhibitor does not improve overall survival. Patients on Rubraca lived for a median 19.4 months, whereas patients on chemotherapy lived for a median 25.4 months.

After discussing this data with the FDA, the drugmaker last month voluntarily withdrew this Rubraca indication in the US. The drug had been available in the US under accelerated approval since 2016. The company said in a SEC filing on June 16 that it had requested voluntary withdrawal in the EU as well.

According to Clovis, the third-line treatment indication in Europe made up a very small portion of the company's total sales of the drug, and that Germany and the Netherlands were the only two countries in Europe that had agreed to reimburse for the drug in this setting while it was on the market conditionally.

Meanwhile, during the American Society of Clinical Oncology's annual meeting in June, the company reported and published in the Journal of Clinical Oncology data from the Phase III ATHENA trial showing that Rubraca significantly improved progression-free survival over placebo as a first-line treatment in advanced ovarian cancer regardless of whether they had BRCA1/2 mutations or homologous recombination repair deficiency. This is a much bigger patient population than the recently pulled ovarian cancer indication and is in line with Clovis' strategy to expand Rubraca's label and drive revenue growth.

Rubraca is also approved in both the US and EU as a maintenance treatment for ovarian, fallopian tube, and primary peritoneal cancer patients who experience complete or partial responses to platinum-based chemotherapy. In issuing its recommendation to restrict the drug's label, CHMP emphasized that the opinion does not affect the maintenance treatment indication.