The Food and Drug Administration (FDA) has granted accelerated approval for Rubraca (rucaparib; Clovis Oncology) for the treatment of advanced ovarian cancer in women have been treated with two or more chemotherapies and whose tumors have deleterious BRCA mutation as identified by an FDA-approved companion diagnostic test.
Rubraca is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA. This action may result in the DNA inside cancerous cells with damaged BRCA genes to be less likely to be repaired, leading to cell death and a possible delay or stoppage of tumor growth.
In addition to Rubraca, the FDA also approved the companion diagnostic for use with Rubraca called FoundationFocus CDxBRCA. This next-generation-sequencing companion diagnostic test detects the presence of deleterious BRCA gene mutations in the tumor tissue. If one or more of the mutations are identified, the patient may be eligible to receive Rubraca.
Rubraca was evaluated in two single-arm clinical studies (n=106) that enrolled patients with BRCA-mutated advanced ovarian cancer who were treated with two or more chemotherapy regimens. Through the FoundationFocus CDxBRCA companion diagnostic, 96% of BRCA gene mutations were confirmed in tested patients with available tumor tissue sample. The studies measured the percentage of participants who experienced partial or complete tumor shrinkage (overall response rate). The data showed 54% of patients who received Rubraca had partial or complete shrinkage of their tumors for a median of 9.2 months.