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FDA Grants Samumed ODD

For SM08502 for the treatment of pancreatic cancer

By: Betsy Louda

, Contract Pharma

Samumed, LLC announced that the U.S. Food and Drug Administration granted orphan drug designation (ODD) for SM08502 for the treatment of pancreatic cancer. 

 
A phase 1, open‐label, multicenter, dose escalation study is currently evaluating the safety, tolerability, and pharmacokinetics (PK) of orally administered SM08502 in subjects with advanced solid tumors.
“The FDA ODD designation for SM08502 is an important regulatory milestone and highlights the importance of finding treatments for a significant unmet need in pancreatic cancer,” said Dr. Yusuf Yazici, chief medical officer of Samumed.

Pancreatic cancer is the fourth leading cause of cancer death in both sexes. Symptoms do not usually appear until the cancer has progressed to late stages, which contributes to the high mortality rate. Risk factors include cigarette smoking, obesity, diabetes, excessive alcohol consumption, and a family history of pancreatic cancer.1
 

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