(Alliance News) - AstraZeneca PLC on Wednesday said Lynparza has been approved in the EU to treat patients with BRCA-mutated metastatic pancreatic cancer.
Astra is developing Lynparza with US drug maker Merck & Co Inc. The Cambridge-based drugmaker said the EU approval follows an approval recommendation from the Committee for Medicinal Products for Human Use and was based on results from the phase 3 Polo trial.
The trial met its primary endpoint of statistically-significant and clinically-meaningful improvement progression-free survival versus placebo.
Pancreatic cancer has the lowest survival rate among the most common cancers. Around 5% to 7% of patients with metastatic pancreatic cancer have a germline BRCA mutation. BRCA mutations are associated with certain cancers.
"Today's approval opens the door to a new era of biomarker-led care for patients with metastatic pancreatic cancer in the EU, which has the highest incidence of any region globally," said Hedy Kindler, co-principal investigator of the Polo trial.
Shares in AstraZeenca were up 0.1% at 8,547.00 pence in London on Wednesday morning.
By Anna Farley; annafarley@alliancenews.com
Copyright 2020 Alliance News Limited. All Rights Reserved.
Astrazeneca (AZN)