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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Ref: PRNewswire | Image: AstraZeneca
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Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at [email protected].
