AstraZeneca (AZN) - Get Report and Merck (MRK) - Get Report were cleared by the Food and Drug Administration to market Lynparza as a maintenance treatment for certain adults with advanced pancreatic cancer, the companies said Monday.
The FDA clearance expands the uses of Lynparza. The drug is already approved for maintenance treatment of certain ovarian cancers and metastatic breast cancer.
An FDA cancer-drug panel two weeks ago had recommended approval of the drug for advanced pancreatic cancer based on a Phase III study, the pharma giants said.
Lynparza, generically olaparib, enabled patients to live without the disease progressing for a median of 7.4 months compared with 3.8 months for those taking a placebo.
In the trial, the safety and tolerability profile of the drug was in line with that seen in earlier clinical trials, they said.
The drug is designed for patients with gBRCAm metastatic pancreatic cancer. The disease is aggressive and few treatment advances have been made in recent decades, Dave Fredrickson, AstraZeneca’s executive vice president for the oncology business unit, said in a statement.
In the U.S. in 2019, more than 55,000 people will have been diagnosed with pancreatic cancer and more than 45,750 people will have died from it, the companies estimated.
Early diagnosis of pancreatic cancer is difficult because often people show no symptoms from it, they said.
In July 2017 the companies said they would partner to market Lynparza and a new medicine, selumetinib, for various types of cancer.
Shares of Merck, Kenilworth, N.J., were little changed in premarket trading. They closed 0.2% higher at $91.50 on Friday. The ADRs of U.K.-based AstraZeneca were 0.8% higher in the premarket. They closed up 1.2% at $50.44 on Friday.