Delcath Systems announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to melphalan for the treatment of cholangiocarcinoma.

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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.