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Promising Drug FL118 Receives FDA's Orphan Drug Designation for Pancreatic Cancer Treatment

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Ayanna Amadi
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Promising Drug FL118 Receives FDA's Orphan Drug Designation for Pancreatic Cancer Treatment

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A New Hope in Pancreatic Cancer Treatment

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The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation to Canget BioTekpharma LLC for FL118, a promising drug candidate developed at Roswell Park Comprehensive Cancer Center for the potential treatment of pancreatic cancer. This designation is a significant part of an incentive program aimed at encouraging the development of new treatments for rare diseases like pancreatic cancer.

What is FL118?

FL118, also known as 10,11-methylenedioxy-20(S)-camptothecin (10,11-MD CPT), is derived from camptothecin, a component found in a tree native to China and used in traditional Chinese medicine. The drug has shown promise in preclinical studies in eliminating pancreatic and colorectal tumor cells. It does this by binding to DDX5, a powerful cancer-causing protein.

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The Importance of Orphan Drug Designation

The Orphan Drug Designation is granted only to drugs that show promise in treating rare diseases. FL118 is one of only 206 pharmaceutical agents granted this designation for the treatment of pancreatic cancer since the FDA initiated the incentive program in 1984. This designation provides crucial incentives such as tax credits, exclusive marketing rights, and exemptions from user fees to support research. In addition, it provides 7 years of market exclusivity upon approval.

Why is this Significant?

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Pancreatic cancer, although it only accounts for 3% of all cancers in the U.S., is projected to become the second most common cause of cancer-related deaths in the U.S. by 2030. Therefore, new treatments like FL118 are urgently needed. This designation is a critical step in speeding up the development and availability of such treatments.

Continued Research and Development

Research recently published in the American Chemical Society's Journal of Medicinal Chemistry documents the synthesis, identification, and characterization of new analogs of FL118 shown to have enhanced comparative antitumor activity. Canget BioTekpharma, a Roswell Park spinoff company, was formed specifically to develop FL118.

Conclusion

The Orphan Drug Designation of FL118 by the FDA signifies a significant milestone in the fight against pancreatic cancer. It not only recognizes the potential of this promising drug but also provides essential incentives to facilitate its continued development and eventual application. As research continues and FL118 moves closer to clinical use, it brings hope to countless patients battling this devastating disease.

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