AstraZeneca gets EU approval for Lynparza
AstraZeneca announced on Wednesday, alongside its partner MSD, that 'Lynparza’, or olaparib, has been approved in the European Union for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
The FTSE 100 pharmaceuticals giant described pancreatic cancer as a rare, life-threatening disease with the lowest survival rate among the most common cancers.
Between 5% and 7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.
The company said the approval by the European Commission was based on results from the phase 3 ‘POLO’ trial, as published in the New England Journal of Medicine.
It followed the recommendation for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
“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 and professor of medicine at the University of Chicago Medicine.
“Lynparza now provides clinicians with a targeted, well-tolerated treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.”
Dave Fredrickson, executive vice-president of AstraZeneca’s oncology business unit, added that metastatic pancreatic cancer had historically faced poor outcomes, due to the aggressive nature of the disease and the few treatment advances made in recent decades.
“In the POLO trial, Lynparza nearly doubled median progression-free survival versus placebo after first-line chemotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer.
“This approval underscores the importance of testing all patients for germline BRCA mutations at the time of diagnosis, as it will help inform personalised treatment options for patients in the EU.”
AstraZeneca said the POLO trial demonstrated that Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death, to a median of 7.4 months, compared to 3.8 months on placebo.
It is approved in the United States and several other countries as a first-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer, based on the phase 3 POLO trial, with ongoing regulatory reviews in other regions.