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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