Great news comes to those who are battling ovarian cancer, a drug called Rubraca. The use of the Clovis Oncology Inc. drug has been approved by the FDA for women who are already in the advanced stages and who have already had a minimum of two chemotherapy sessions.
The FDA's fast approval was garnered to the Clovis medication as it gave promising results in battling cancer. The drug works by targeting a specific gene mutation referred to as deleterious BRCA. This gives women with gene abnormalities another option to try for their treatment.
The BRCA genes are responsible for repairing damaged DNA and tumor development prevention. Once a mutation takes place, the possibility of acquiring cancers like ovarian cancer is greatly heightened. This is where Rubraca comes in.
Rubraca, being a poly ADP-ribose polymerase (PARP) inhibitor uses a mechanism that involves the blockage of an enzyme that repairs damaged DNA. Once this enzyme is blocked, damaged DNA within the cancerous cells with damaged BRCA genes are less likely to be repaired, thereby causing a slow and eventual death or halt in tumor growth.
Along with the Clovis drug approval is the FDA's go signal to the FoundationFocus CDxBRCA companion diagnostic for use with Rubraca. This test detects deleterious BRCA genes in the tumor tissues of the ovarian cancer sufferers. Having one or more detections will qualify them for the treatment.
The agency reportedly cleared the drug and gave it a fast approval because of a study conducted in 100 women. The result had 54 patients declare a complete or partial shrinkage of their tumors. Rubraca comes with promising results, hence, earning a spot in the accelerated approval slate. If by any chance the drugs expected benefits do not materialize, FDA can order its removal from the market, NBC News reported.
The new ovarian cancer drug comes with risks of creating bone marrow problems and a blood cancer referred to as acute myeloid leukemia. Nausea, fatigue, low levels of RBC and vomiting may be noted as its common side effects.