Maintenance rucaparib approved for US recurrent ovarian cancer patients
medwireNews: The US FDA has granted approval for use of the PARP inhibitor rucaparib as a maintenance therapy for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Rucaparib is recommended for the treatment of women who have achieved a complete or partial response to platinum-based chemotherapy at an oral dose of 600 mg twice daily with or without food.
The FDA announcement follows the recent adoption by the EMA of a positive opinion for use of rucaparib in this patient population based on results from the ARIEL3 trial. The study demonstrated improved median progression-free survival with rucaparib versus placebo, including in subgroups of patients with homologous recombination deficiency (HRD) and those whose tumours harbor a deleterious somatic or germline BRCA mutation.
A complementary diagnostic test for HRD status has also been approved by the US FDA.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group