Senhwa's Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer
"We are pleased to receive ODD for Silmitasertib for the treatment of Biliary Tract Cancer, a rare, malignant disease for which there are no effective therapies.
- "We are pleased to receive ODD for Silmitasertib for the treatment of Biliary Tract Cancer, a rare, malignant disease for which there are no effective therapies.
- Biliary tract cancer (BTC) refers to a group of rare, diverse and aggressive cancers that arise from the bile duct system.
- BTCs are classified into four distinct subtypes based on the tissue where the cancer originates including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), gallbladder cancer (GBC) and ampullary cancer.
- The US FDA has granted Silmitasertib key drug designations: Orphan Drug Designation for the treatment of Cholangiocarcinoma inDecember 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma inJuly 2020and December 2021, respectively.Fast Track Designation was granted inAugust 2021for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma.