Other safety alerts
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| The United Kingdom: Rucaparib (Rubracaâ–¼): withdrawal of third-line treatment indication |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that the third-line treatment indication for rucaparib has been withdrawn following a review of the findings of the ARIEL-4 trial, which showed lower overall survival for rucaparib treatment versus standard chemotherapy in patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.
Rucaparib was granted a conditional approval in 2018, pending the ARIEL-4 study confirming its safety and effectiveness in the third-line treatment indication. The ARIEL-4 study compared outcomes for rucaparib versus chemotherapy in treatment of patients whose cancer had relapsed after at least 2 previous treatments and who were still eligible for further chemotherapy. The final analysis showed lower overall survival with rucaparib versus chemotherapy (19.4 months versus 25.4 months, respectively, hazard ratio of 1.31 (95% CI 1.00 to 1.73; p=0.0507)).
A European review of these findings has recommended withdrawal of the third-line treatment indication since the benefits of Rubraca when used in this indication had not been confirmed and treatment may be associated with an increased risk of death. The MHRA has reviewed the recommendation and agreed with this removal of indication in the United Kingdom.
Advice for healthcare professionals:
- Final analysis of the ARIEL-4 study findings showed lower overall survival with rucaparib versus standard chemotherapy control in the treatment of relapsed, BRCA-mutated, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Rucaparib should no longer be used for third-line cancer treatment in new patients.
- Inform patients already receiving rucaparib for the third-line treatment indication of the latest data and recommendations, and consider other treatment options.
- This advice does not affect use of rucaparib in maintenance of patients who are in response (complete or partial) to platinum-based chemotherapy.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/rucaparib-rubracav-withdrawal-of-third-line-treatment-indication
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Sep 27, 2022
Issued at HKT 16:00
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