Delcath Systems announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to melphalan for the treatment of cholangiocarcinoma.
Recently Delcath Systems announced the expansion of its global Phase 2 clinical study in primary liver cancer (HCC) to include an intrahepatic cholangiocarcinoma (ICC) cohort, which is investigating the safety and efficacy of Melphalan/HDS treatment in patients with unresectable ICC confined to the liver. The ICC cohort will evaluate tumor response (objective response rate), progression-free survival, and safety. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as to assess patient-reported clinical outcomes, or quality-of-life.
For more information visit Delcath.com.