Lynparza (olaparib) has been approved in the US as a 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer.
The decision means that the joint MSD and AstraZeneca PARP inhibitor is the first of its kind to be approved in pancreatic cancer, as well as being the drug’s third tumour type and fifth indication in the US.
Specifically, the new indication is for adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic versions of the disease, for patients whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen.
The approval follows the recommendation from the US FDA Oncologic Drugs Advisory Committee (ODAC) on 17 December, which was decided on the back of results from the Phase III POLO trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival.
In the trial Lynparza demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, nearly doubling the time that patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death.
Metastatic pancreatic cancer patients have “been waiting a long time for new therapy options for their devastating disease” explained Julie Fleshman, president and chief executive officer, Pancreatic Cancer Action Network.
There are currently no precision medicine treatment options for gBRCAm pancreatic cancer patients, making it an area of high unmet need.
Julie continued, “Today’s approval of Lynparza provides an exciting new treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.”
Pancreatic cancer is a deadly cancer with a high unmet medical need, and is the 12th most commonly occurring cancer. There were approximately 460,000 new cases worldwide in 2018.