AstraZeneca and Merck & Co., Inc. announced that Lynparza (olaparib) has been approved in the US for the maintenance treatment of adult patients with a type of metastatic pancreatic cancer.
Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparz. The drug was co-developed by AZ and Merck.
AstraZeneca employs nearly 1,500 people in Delaware in administrative and logistics operations.
The approval follows the recommendation by the US FDA Oncologic Drugs Advisory Committee (ODAC) on December 17 for Lynparza in this indication and was based on results from a late-stage trial.
Results showed a clinically meaningful improvement in progression-free survival, where the drug nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo, AstraZeneca stated.
Dave Fredrickson, executive vice president, Oncology Business Unit, said: “Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades. Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer.”
Pancreatic cancer has been in the news with popular Jeopardy game show host Alex Trebek disclosing that he is fighting an advanced case of the disease.
Julie Fleshman, CEO, Pancreatic Cancer Action Network, said: “Metastatic pancreatic cancer patients have been waiting a long time for new therapy options for their devastating disease. Today’s approval of Lynparza provides an exciting new treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.”
Side effects have led to dose reduction in 17 percent of patients on Lynparza while six percent of patients discontinued treatment.
Lynparza is currently approved for the maintenance treatment of certain types of breast and ovarian cancers.
First-half sales of Lymparza totaled $520 million. The cost of 112 pills runs nearly $3,400 for those without coverage. A patient assistance program is available from AstraZeneca.