Dec 17, 2019: AstraZeneca and MSD announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend Lynparza (olaparib) as a 1st-line maintenance monotherapy for the patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of pancreas (pancreatic cancer), whose disease has not progressed following 1st-line platinum-based chemotherapy.
The NDA submission was based on the positive results from the Phase III POLO trial that results in 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 risk ratio of 0.53.
Lynparza almost doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a average of 7.4 months vs. 3.8 months on placebo.
The advantage of maintenance with Lynparza was seen over and over across a range of clinically meaningful endpoints. From six months onwards, more than double the patients treated with Lynparza showed no disease progression vs. those on placebo.
In patients with assessable disease at baseline, 23% responded to Lynparza vs.12% on placebo and had a median duration of the treatment in excess of two years (24.9 months) vs 3.7 months on placebo. https://www.astrazeneca.com/media-centre/press-releases/2019/lynparza-recommended-by-fda-advisory-committee-for-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer.html