FDA approves drug for treating pancreatic cancer
The U.S. Food and Drug Administration has cleared the ovarian cancer drug Lynparza to treat advanced pancreatic cancer, according to AstraZeneca and Merck, the companies that developed it.
An FDA spokesperson confirmed the approval. A panel at the agency this month recommended Lynparza after a study found that pancreatic cancer patients taking the drug went almost twice as long without their cancer getting worse than those taking a placebo.
The FDA approved Lynparza's use as a maintenance treatment for those with so-called BRCA gene mutations whose cancer had spread beyond the pancreas and whose tumors did not grow after at least 16 weeks of chemotherapy, AstraZeneca and Merck said Monday in a joint news release. Whether a patient meets those criteria is determined by an FDA test.
Mutations in BRCA genes hinder the body's ability to fix DNA damage, making it more likely that cells develop genetic alterations that can lead to cancer, the companies explained. Lynparza is among the drugs known as PARP inhibitors, which are used to stop cancer cells from reproducing.
"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," Dave Fredrickson, executive vice president of AstraZeneca's oncology business unit, said in a statement.
"Metastatic pancreatic cancer patients have been waiting a long time for new therapy options for their devastating disease," Julie Fleshman, president and CEO of Pancreatic Cancer Action Network, added.
Pancreatic cancer is particularly deadly because it often goes undetected until it's in advanced stages. The American Cancer Society estimates that nearly 46,000 Americans will die of the disease this year.
In 2017, AstraZeneca and Merck announced a joint effort to develop and market Lynparza to treat multiple types of cancer. The drug is already approved to treat ovarian and breast cancer.