The U.S. Food and Drug Administration (FDA) has granted approval to Lynparza (olaparib) for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with at least three prior lines of chemotherapy.
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor that exerts its anticancer activity by blocking enzymes associated with repairing damaged DNA. It is the first drug in its class to be approved by the U.S. FDA.
The recommended dose for Lynparza is 400mg orally twice daily and treatment should be continued until disease progression or unacceptable toxicity.
Approval is based on findings that 34% of patients with gBRCAm-associated ovarian cancer experienced an objective response rate for an average of 7.9 months. The most common adverse events were fatigue, nausea, abdominal pain/discomfort, vomiting, and diarrhea. The most common lab abnormalities included anemia, mean corpuscular volume elevation, lymphopenia, creatinine elevation, and thrombocytopenia.
The FDA also approved the BRACAnalysis CDx diagnostic test to detect the presence of BRCA mutations in blood samples to be used before a patient is treated with Lynparza.
Lynparza was approved under the FDA’s accelerated approval program.