FDA Approves New Pancreatic Treatment Found To Double Time Patients Live Without Disease Progression


 
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By Dana Dovey

Pancreatic cancer is notoriously aggressive and difficult to treat but a recent FDA ruling may help put odds more in patients’ favor. Last week the FDA approved Lynparza for use as a maintenance treatment for certain pancreatic cancer patients. The drug was found to significantly expand the amount of time patients lived without disease progression.

Chances are you’ve already heard of Lynparza. The PARP inhibitor is currently approved in various countries for the maintenance treatment of certain types of ovarian cancer and breast cancer. Now, the drug can add pancreatic cancer to its repertoire. Lynparza works by preventing cells that have been destroyed by chemotherapy from repairing themselves. As a result, cancer progression is slowed.

Lynparza is now approved for use as the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen, a press release from the drug manufacturer, Astra Zeneca, reported.

The recent approval is based on results from clinical trials. In the Phase III trial, dubbed POLO, the drug was given to 154 patients with gBRCAm metastatic pancreatic cancer whose disease had not progressed on 1st-line platinum-based chemotherapy. Patients who received Lynparza lived nearly twice as long without their disease worsening than those who received the placebo. For example, those who received Lynparza went an average of 7.4 months before their disease began to worsen.

However, the overall survival of patients at the interim analysis, or the analysis of data that was conducted before data collection has been completed, was only 18.9 months for Lynparza versus 18.1 months for the placebo. In other words, not statistically significant.

Still, the results have been taken positively. Pancreatic cancer is the 12th most commonly occurring cancer and the 7th most deadly, with survival rates far below other forms of cancer.

“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,” said Dave Fredrickson, the Executive Vice President of Oncology Business Unit, said in a press release. “Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer.”

The drug is specifically beneficial for patients with advanced pancreatic cancer who carry BRCA gene mutations. The BRCA gene mutation, which gained public attention for its association with breast cancer, and less notably ovarian cancer, is a genetic mutation that interferes with DNA’s ability to repair damage. As a result, the progression of cancers associated with BRCA gene mutations tend to spread faster, Reuters reported.

Patients will be selected for Lynparza therapy based on an FDA-approved companion diagnostic.

 
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