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FDA grants YS-ON-001 orphan drug designation for pancreatic cancer
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The FDA granted orphan drug designation to YS-ON-001, an immuno-oncology biologic product, for the treatment of pancreatic cancer, according to the agent’s manufacturer.
YS-ON-001 (Yisheng Biopharma) previously received orphan drug designation for the treatment of hepatocellular carcinoma.
“YS-ON-001 is an emerging immuno-oncology product with multiple modes of action in changing tumor microenvironment, such as induction of antitumor cytokines, activation of [natural killer] cells, regulation of macrophage polarization and suppression of regulatory T cells,” Zhang Yi, chairman of Yisheng Biopharma, said in a press release. “We believe it has great potential to become a monotherapeutic agent or be combined with standard-of-care chemotherapies, targeted therapies and checkpoint inhibitors, or with other emerging immunotherapies that produce additive or synergistic treatment effects.”
“The orphan drug designation of YS-ON-001 in pancreatic cancer is an important regulatory milestone as it will accelerate our clinical development in this particular oncology indication where pancreatic cancer is one of the deadliest cancers and is estimated to be the fourth leading cause of cancer-related death in the United States in 2018, according to the American Cancer Society,” Hui Shao, president and CEO of Yisheng Biopharma, said in the release.
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.