AstraZeneca’s Imfinzi (durvalumab) + Tremelimumab Receive the US FDA’s Orphan Drug Designation for Liver Cancer

Shots:

• The ODD is based on P-III HIMALAYA study assessing Imfinzi as monothx., a combination of Imfinzi and tremelimumab vs SOC (sorafenib) in patients with unresectable advanced HCC, prior not treated with systemic therapy across 16 countries including the US, EU, Canada, South America and Asia
• The US FDA grants ODD to therapies intended to treat, diagnose or prevent rare diseases or disorders affecting fewer than 200,000 people in the US
• Imfinzi (durvalumab) is a mAb targeting PD-L1, blocking the interaction of PD-L1 with PD-1 and CD80, approved in 54 countries for stage III NSCLC following CRT with its expected PDUFA date in Q1’20

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