Nadunolimab Drug Granted Orphan Drug Designation

Release Date: 06-Oct-2021

US FDA has granted Orphan Drug Designation to Nadunolimab (CAN04) to cure the pancreatic cancer. Nadunolimab is currently evaluated in ongoing clinical trials for treatment of PDAC. A phase I study, CAPAFOUR, was started in H1’2021 and investigates CAN04 in combination with the chemotherapy regimen FOLFIRINOX for first line treatment of metastatic PDAC. Currently, PDAc accounts for 90% of all cases of pancreatic cancer.


Another phase I study, CIRIFOUR, is also currently investigating CAN04 combined with an immune checkpoint inhibitor, with or without chemotherapy, and was started H2 2020. Additional clinical combination studies with CAN04 are planned to initiate treatment of patients during 2021.


The FDA Orphan Drug Designation Program gives orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the US and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.

Need custom market research solution? We can help you with that too.