AstraZeneca and Merck said on Wednesday their blockbuster cancer treatment Lynparza won approval in the European Union for treating patients with a form of pancreatic cancer.
The approval was based on results from a late-stage trial in which Lynparza nearly doubled the lifespan of patients without disease progression or death when compared with placebo.
Lynparza, which can now be used to treat patients with a form of BRCA-mutated metastatic pancreatic cancer, leads a class of drugs known as PARP inhibitors that stop cancer cells from repairing themselves after being damaged by chemotherapy.
The approval by the European Commission was based on results from the Phase III POLO trial, which were published in The New England Journal of Medicine. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Hedy L. Kindler, Co-Principal Investigator of the POLO trial and Professor of Medicine, University of Chicago Medicine, said: “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. 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, Oncology Business Unit, said: “Patients with metastatic pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and few treatment advances have been made over the last few decades. In the POLO trial, Lynparza nearly doubled median progression-free survival versus placebo after 1st-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.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “MSD and AstraZeneca are committed to advancing research into the treatment of patients with challenging types of cancer, including those with metastatic pancreatic cancer. Lynparza is now the only approved PARP inhibitor in biomarker-selected patients with metastatic pancreatic cancer. We look forward to making this targeted treatment option available for patients across the EU as quickly as possible.”
The drug is already approved in the US and several other countries as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer.
Pancreatic cancer is a deadly cancer with a high unmet medical need. Globally, pancreatic cancer is the 11th-most commonly occurring cancer and the seventh leading cause of cancer death.
