Policy & Regulation
Cantargia receives positive EMA opinion for orphan designation of nadunolimab in pancreatic cancer
14 October 2021 -

Swedish biotechnology company Cantargia AB (STO:CANTA) announced on Thursday a positive opinion from European authorities for orphan designation of nadunolimab (CAN04) for treatment of pancreatic cancer.

The positive opinion from the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) was based on data from the ongoing CANFOUR trial, a phase I/IIa study in which CAN04 is being investigated in patients with advanced pancreatic ductal adenocarcinoma (PDAC) as first-line combination with gemcitabine and nab-paclitaxel.

The European Commission is now expected to grant the orphan designation within 30 days.

CAN04 was granted orphan drug designation for treatment of pancreatic cancer by the US Food and Drug Administration (FDA) in September 2021.

An interleukin-1 receptor accessory protein (IL1RAP)-binding antibody, CAN04 is currently being investigated in multiple clinical trials evaluating combination with chemotherapy regimens in various forms of cancer, including PDAC, the most common form of pancreatic cancer.

Login
Username:

Password:


Related Headlines