The approval was based on results from a late-stage trial in which Lynparza nearly doubled the lifespan of patients
AstraZeneca and Merck & Co said 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 comes more than a month after the drug received a positive recommendation from the European Medicines Agency for the same indication.
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 comes more than a month after the drug received a positive recommendation from the European Medicines Agency for the same indication.
Lynparza became the first marketed PARP drug with a US approval for ovarian cancer in 2014 and is key to AstraZeneca’s push in oncology and sustaining the company’s turnaround.