AstraZeneca Reports the US FDA Acceptance of sBLA and Granted Priority Review for Imfinzi (durvalumab) to Treat Patients with Extensive-Stage Small Cell Lung Cancer

 AstraZeneca Reports the US FDA Acceptance of sBLA and Granted Priority Review for Imfinzi (durvalumab) to Treat Patients with Extensive-Stage Small Cell Lung Cancer

AstraZeneca Reports the US FDA Acceptance of sBLA and Granted Priority Review for Imfinzi (durvalumab) to Treat Patients with Extensive-Stage Small Cell Lung Cancer

Shots:

  • The sBLA is based P-III CASPIAN study assessing Imfinzi + SOC (etoposide with either cisplatin or carboplatin)/ Imfinzi + tremelimumab + CT vs CT as monothx. in patients with previously untreated extensive-stage SCLC in 200+ centers across 23 countries
  • The P-III CASPIAN study demonstrated improvement in OS (13.0 cs 10.3 mos.) with a reduction in risk of death by 27%, @18mos. alive patients (33.9% vs 24.7%). The PDUFA is set for Q1’20
  • Imfinzi 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 chemoradiation therapy

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Health Economic Times

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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