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

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

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

Click here ­to­ read full press release/ article | Ref: AstraZeneca  | Image: AstraZeneca

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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