Italian Medicines Agency Agenzia Italiana del Farmaco

EMA recommends restricting use of cancer medicine Rubraca - EMA recommends restricting use of cancer medicine Rubraca

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EMA recommends restricting use of cancer medicine Rubraca

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.

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.

This recommendation does not affect the use of Rubraca as maintenance treatment following chemotherapy.


Published on: 25 July 2022

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