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

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