FDA panel recommends olaparib for pancreatic cancer

February 6, 2020 0 By FM

AstraZeneca and MSD Inc said the US FDA Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend olaparib (Lynparza) as a 1st-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas, whose disease has not progressed following 1st-line platinum-based chemotherapy.

Olaparib is a PARP inhibitor. In August 2019, the FDA accepted the supplemental New Drug Application (sNDA) for olaparib for this indication with Priority Review and set a Prescription Drug User Fee Act (PDUFA) date for the fourth quarter of 2019.

The sNDA submission was based on the positive results from the phase III POLO trial published in The New England Journal of Medicine. The results showed a statistically significant and clinically meaningful improvement in progression-free survival and reduced the risk of disease progression or death by 47% based on a hazard ratio of 0.53 (p=0.0038). 

Olaparib nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo.

In addition to the US, olaparib is currently under regulatory review in the EU, Canada and other jurisdictions as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer.