publication date: Apr. 13, 2018
Drugs and Targets Rucaparib approved for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
FDA approved rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
The agent is sponsored by Clovis Oncology Inc.
Approval was based on ARIEL3 (NCT01968213), a randomized, double-blind, placebo-controlled trial in 561 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with at least two prior treatments of platinum-based chemotherapy and were in complete or partial response to the most recent platinum-based chemotherapy. Patients were randomized (2:1) to rucaparib 600 mg orally twice daily (n=372) or placebo (n=189) and were treated until disease progression or unacceptable toxicity.
Tumor tissue samples were examined with a next-generation sequencing assay to determine whether DNA contained a deleterious somatic or germline BRCA mutation. This test was also used to determine the percentage of genomic loss of heterozygosity.
Positive homologous recombination deficiency status was defined as tBRCA-positive and/or LOH high. Three patient outcomes analyses were performed on the following groups: all patients, HRD subgroup, and tBRCA subgroup.
ARIEL3 demonstrated a statistically significant improvement in estimated median progression-free survival assessed … Continue reading Rucaparib approved for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
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