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Cantargia’s Nadunolimab Aantibody Awarded US FDA Fast Track Designation
Fast Track Designation (FTD) granted for the treatment of patients with metastatic PDAC with high IL1RAP expression levels. Reflects high unmet medical need in metastatic PDAC. Facilitates further development of nadunolimab with more frequent FDA ...
About this update from Cantargia Ab
[{"type":"list","items":[{"val":[{"type":"text","content":"Fast Track Designation (FTD) granted for the treatment of patients with metastatic PDAC with high IL1RAP expression levels.","length":123,"tagName":"p"}]},{"val":[{"type":"text","content":"Reflects high unmet medical need in metastatic PDAC.","length":52,"tagName":"p"}]},{"val":[{"type":"text","content":"Facilitates further development of nadunolimab with more frequent FDA interactions and eligibility for Accelerated Approval and Priority Review.","length":144,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":319,"olType":false},{"type":"text","content":"LUND, SE / ACCESS Newswire / June 11, 2025 / Cantargia (Cantargia AB (publ); NASDAQ Stockholm: CANTA), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to nadunolimab, Cantargia's anti-IL1RAP antibody for the treatment of patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC) with high expression levels of IL1RAP in combination with gemcitabine and nab-paclitaxel. The FTD follows strong clinical data from the CANFOUR study showing a two-year survival of 35%, an overall survival (OS) of 14.2 months and overall response rate (ORR) of 48% in this patient population.","length":655,"tagName":"p"},{"type":"text","content":""The recognition from the FDA for our clinical and translational data on nadunolimab and the future path in pancreatic cancer is an outstanding development for Cantargia. The support from the FDA for the continued development of nadunolimab in the high IL1RAP subset of PDAC patients further strengthens our efforts to bring this potentially important new treatment to these patients who currently lack options", said Damian Marron, CEO of Cantargia.","length":460,"tagName":"p"},{"type":"text","content":"Fast Track Designation is a tool and a process designed by the FDA to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. The benefits of a Fast Track Designation include:","length":307,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"More frequent meetings and communication with the FDA.","length":54,"tagName":"p"}]},{"val":[{"type":"text","content":"Eligibility for Accelera...