EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancers of the ovary, fallopian tubes or peritoneum with a BRCA mutation in patients whose cancer has come back after at least two platinum-based chemotherapies and who cannot have further platinum-based therapy.
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The recommendation follows the review of final data from the ARIEL4 study, which compared Rubraca with chemotherapy in patients whose cancer had come back after at least two previous treatments and who were still eligible for further chemotherapy.
The final analysis of overall survival showed that Rubraca was not as effective as chemotherapy at prolonging patients’ lives: those treated with Rubraca lived for an average of 19.4 months, compared with 25.4 months for patients receiving chemotherapy.
As a result, doctors should not start third-line treatment with Rubraca in new patients. Doctors should inform patients already receiving Rubraca for this indication of the latest data and recommendations, and consider other treatment options.
A difference in favour of Rubraca was observed for the primary endpoint of progression free survival by investigator (invPFS) (7.4 months for the Rubraca group compared with 5.7 months for the chemotherapy group (hazard ratio (HR)=0.665 (95% CI: 0.516, 0.858); p=0.0017)).
However, overall survival with Rubraca was lower than that with chemotherapy (19.4 months versus 25.4 months, respectively, with a HR of 1.31 (95% CI: 1.00, 1.73); p=0.0507).
The CHMP therefore concluded that the benefit of Rubraca, when used in the above-mentioned indication, had not been confirmed and that treatment may be associated with an increased risk of death.
Ongoing treatment in this setting should be reconsidered and patients should be informed of the latest data and recommendations.
This recommendation does not affect the use of Rubraca as maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. ■