AstraZeneca and Merck announced that Lynparza has been recommended for marketing authorization in the European Union (EU) for the 1st-line maintenance treatment of patients with a type of advanced pancreatic cancer.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III POLO trial, which were published inThe New England Journal of Medicine.
The 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 versus 3.8 months on placebo.
José Baselga, executive vice president, Oncology R&D, said: “Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades. We are now one step closer to bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU.”
Lynparza is approved in the US and several other countries as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer based on the Phase III POLO trial, with ongoing regulatory reviews in the EU and other jurisdictions.
Pancreatic cancer has the lowest survival rate of the most common cancers.Globally, pancreatic cancer is the 11th-most commonly occurring cancerand the seventh leading cause of cancer death.
There were approximately 460,000 new cases worldwide in 2018.As there are often no symptoms or symptoms may be non-specific in the early stages, it is most commonly diagnosed at an incurable stage.4,5
Around 80% of pancreatic cancer patients are diagnosed when the disease has metastasized, at which point average survival is less than a year.
Despite advances in treatment, few improvements have been made in diagnosis and treatment in the past few decades.
AstraZeneca employs 1,500 in northern Delaware.