The Food and Drug Administration (FDA) has granted accelerated approval for Lynparza (olaparib; AstraZeneca) for the treatment of advanced ovarian cancer associated with defective BRCA genes. Lynparza is approved with the companion diagnostic, BRACAnalysis CDx, to detect the presence of mutations in the BRCA genes in patients’ blood samples.
Lynparza is a first-in-class poly ADP-ribose polymerase (PARP) inhibitor that that works by blocking enzymes associated with repairing damaged DNA.
The efficacy of Lynparza was established in a study where patients with ovarian cancer associated with mutations in the BRCA gene received Lynparza. The study showed that treatment with Lynparza resulted in 34% of patients experiencing an average objective response rate of 7.9 months.
The FDA approval of the BRACAnalysis CDx is supported by data from the clinical trial used to support Lynparza approval. The patients’ blood samples were tested to validate the BRACAnalysis CDx’s detection of BRCA mutations (n=137).
Lynparza and the BRACAnalysis CDx were both reviewed under the FDA’s priority review program.
For more information visit FDA.gov.