FDA grants orphan drug designation to durvalumab-tremelimumab combination for liver cancer

The FDA granted orphan drug designation to the combination of durvalumab plus tremelimumab for treatment of patients with advanced hepatocellular carcinoma.Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1. It inhibits interaction of PD-L1 with PD-1 and CD80. Tremelimumab (MedImmune/AstraZeneca) is an investigational anti-CTLA-4 monoclonal antibody.The ongoing phase 3 HIMALAYA trial is designed to evaluate the combination of durvalumab plus tremelimumab for patients with advanced and unresectable HCC who are ineligible for localized treatment and have notRead More

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