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FDA grants orphan drug designation to BL-8040 for pancreatic cancer
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The FDA granted orphan drug designation to BL-8040 for the treatment of pancreatic cancer.
BL-8040 (BioLineRx Ltd.) is a novel short peptide that functions as a high-affinity antagonist for CXCR4, according to its manufacturer. The agent is in development for treatment of solid tumors and acute myeloid leukemia, as well as for stem cell mobilization for bone marrow transplantation.
“Despite advances in the treatment of various cancers with immune checkpoint inhibitors, pancreatic cancer is refractory to these treatment options and remains an area of significant unmet medical need,” Philip Serlin, CEO of BioLineRx, said in a company-issued press release. “We have previously reported encouraging clinical data supporting the potential of BL-8040 as part of an immunotherapy combination treatment in pancreatic cancer, and we look forward to topline results from our ongoing pancreatic clinical studies later this year.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.