The Pancreatic Cancer Action Network (PanCAN), a leading patient advocacy organization dedicated to fighting the world’s toughest cancer, released a statement today following the U.S. Food and Drug Administration (FDA) approval on NALIRIFOX as a first-line treatment option for metastatic pancreatic cancer.

“We are pleased that the FDA has approved the NALIRIFOX regimen. For a tough disease with few treatment options, this is significant news for people with metastatic pancreatic ductal adenocarcinoma (PDAC) given it has been more than 10 years since there has been a PDAC-specific approval in the first-line setting,” said Julie Fleshman, JD, MBA, president and CEO of PanCAN.

Today’s news marks important progress. Patients faced with metastatic pancreatic cancer need multiple treatment choices. This approval adds a new indication for patients who have not had prior treatment. In a clinical trial, the NALIRIFOX regimen was compared to gemcitabine (Gemzar®) plus nab-paclitaxel (Abraxane®), which is one of the current standard-of-care treatments for patients with metastatic pancreatic cancer. The results showed that patients treated with NALIRIFOX had an overall survival of 11.1 months, which was a statistically significant improvement over the 9.2-month overall survival with gemcitabine and nab-paclitaxel.

“We thank Ipsen for seeking FDA approval for this regimen and are thankful for the patients who participated in the clinical trial. The only way to bring new treatment options to patients is through lab-based research and clinical trials. PanCAN remains committed to providing evidence-based information and resources to patients and caregivers and advancing research to improve patient outcomes,” said Fleshman.

Pancreatic cancer is the third leading cause of cancer-related deaths in the U.S. and is on track to become the second leading cause. The five-year survival rate of just 13% demands immediate action to save lives. Because symptoms are often vague and mimic other illnesses or conditions, most patients are diagnosed when they are already in the late stages of the disease. Finding a pancreatic tumor early when it can be surgically removed is critical for survival. Currently, there is no standard screening test to detect pancreatic cancer early the way there is for other major cancers like mammograms for breast cancer or colonoscopies for colon cancer.