Tags : (durvalumab)

Regulatory

AstraZeneca’s Imfinzi (durvalumab) Receives NMPA’s Approval for Unresectable Stage III

Shots: The approval is based on P-III PACIFIC study assessing Imfinzi vs PBO in 713 ‘all-comer’ patients (regardless of PD-L1 status) with unresectable, Stage III, LA NSCLC whose disease had not progressed following concurrent platinum-based CRT The P-III PACIFIC study results: improvement in OS and PFS; 32% reduction in risk of death; mPFS (16.8 vs […]Read More

Regulatory

AstraZeneca Reports the US FDA Acceptance of sBLA and Granted

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 […]Read More