US FDA approves Rubraca to treat advanced ovarian cancer
The US Food and Drug Administration (FDA) has granted approval to Rubraca (rucaparib) for the treatment of advanced ovarian cancer in women.
The poly ADP-ribose polymerase (PARP) inhibitor Rubraca is approved for women who have been treated with two or more chemotherapies and whose tumours have BRCA gene mutation as identified by a companion diagnostic test approved by the FDA.
Involved with repairing damaged DNA, BRCA genes normally work to prevent tumour development. Mutations of these genes are expected to lead to certain cancers, including ovarian.
Rubraca blocks an enzyme involved in repairing damaged DNA.
Due to this, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, which could potentially result in cell death.
FDA Center for Drug Evaluation and Research office of haematology and oncology products director Richard Pazdur said: “Today’s approval is another example of the trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient’s genes.
“Women with these gene abnormalities who have tried at least two chemotherapy treatments for their ovarian cancer now have an additional treatment option.”
The FDA has also approved the next-generation-sequencing (NGS)-based FoundationFocus CDxBRCA companion diagnostic for use with Rubraca.
With the NGS test, the presence of deleterious BRCA gene mutations in the tumour tissue of ovarian cancer patients can be detected.
Upon detecting one or more of the mutations, the patient may be eligible for treatment with Rubraca.
The safety of Rubraca was studied as part of two, single-arm clinical trials that involved 106 participants with BRCA-mutated advanced ovarian cancer.
Common side effects of the inhibitor include nausea, fatigue, vomiting, low levels of red blood cells (anaemia), abdominal pain, unusual taste sensation (dysgeusia) and constipation, among others.
Image: Ovarian cancer as seen on CT. Photo: courtesy of James Heilman, MD.