AstraZeneca Plc (LON:AZN) announced that the US Food and Drugs Administration (FDA) has approved its Lynparza branded drug as a ‘1st-line maintenance treatment’ for a form of pancreatic cancer.
It follows a recommendation from the US FDA Oncologic Drugs Advisory Committee earlier in December, based on Phase III drug trial results presented the 2019 American Society of Clinical Oncology Annual Meeting.
The trial results showed a statistically significant and clinically meaningful improvement in progression-free survival.
With the new approval, Lynparza will be available to adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer, whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen.
Dave Fredrickson, executive VP of Astrazenca’s oncology unit, said: "Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades.
“Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer."
The Lynparza drug is part owned by AstraZeneca in partnership with MSD - known as Merck & Co Inc in the US and Canada – and it presently approved in 65 countries for the maintenance treatment of platinum-sensitive relapsed ovarian cancer and 44 countries for maintenance treatment in breast cancer patients who have previously had chemotherapy.