According to a story from BioPharma Reporter, the pharmaceutical company Candel Therapeutics recently announced that its investigational therapy designated CAN-2409 has earned Fast Track designation from the US Food and Drug Administration. This drug is in development as a treatment for pancreatic cancer. CAN-2409 received Fast Track status after the company released encouraging findings from its phase 2 trial in November 2023.
The results from the trial included an estimated survival rate of 71.4% at 24 months and at 36 months. Patients received either two or three doses of CAN-2409, along with a prodrug regimen and chemoradiation before undergoing surgery. The placebo group, by comparison, saw an estimated survival rate of only 16.7% in the same timeframe.
In addition, scientists noted changes to the resected tissue of the pancreas in patients that were treated with CAN-2409. The changes suggest that this therapy can stimulate a significant immunological response against the tumor that would otherwise not occur.
About Fast Track Designation
Fast Track designation from the FDA is intended to accelerate the development of medicines designed to address a serious medical condition and fulfill a currently unmet medical need. A drug can be granted Fast Track designation in diseases with other available therapies if the drug shows significant advantages in effectiveness or safety over current therapies. This designation must be requested by the company. Benefits of Fast Track include more frequent interaction with the FDA, eligibility for Rolling Review (which allows for the company to submit BLA/NDA as each section is completed, instead of waiting until the entire application process is complete), and potential eligibility for Accelerated Approval and Priority Review if other relevant criteria are satisfied.
About Pancreatic Cancer
Pancreatic cancer is one of the most dangerous forms of cancer. The disease affects the pancreas, which is a glandular organ that is situated behind the stomach. Part of the reason that pancreatic cancer is so dangerous is that it rarely produces noticeable symptoms until it has reached an advanced stage and begun to spread. However, even when detected earlier, it is difficult to treat effectively. Risk factors for pancreatic cancer include being male, old age, African American ancestry, family history, smoking, obesity, diabetes, chronic pancreatitis, and a diet heavy in red meat, processed meat, or meat cooked at very high temperatures. Symptoms include depression, upper abdominal pain, jaundice, diabetes, constipation, weight loss, and appetite loss. Treatment approaches for this cancer include surgery, chemotherapy, and radiation therapy. Even with heavy treatment, pancreatic cancer almost always returns. The five-year survival rate is just 10%. To learn more about pancreatic cancer, click here.
