Innovent and Eli Lilly Receive the NMPA’s Approval of Tyvyt (sintilimab) sNDA for EGFR-Mutated Non-Squamous NSCLC
Shots:
- The NMPA has approved sNDA for Tyvyt in combination with bevacizumab & CT for EGFR-mutated non-sq. NSCLC who progressed after EGFR TKI therapy
- The approval was based on the P-III trial (ORIENT-31) evaluating Tyvyt with/out Byvasda & CT vs CT alone in 600 patients. As of the data cut-off date Mar 2022 in 2nd interim analysis, sustained PFS benefit was reported in the ITT population, m-PFS (7.2 vs 4.3mos.). In the 2EPs, improvement in ORR & DoR was seen
- As of the data cutoff date July 2022, OS benefit was seen, m-OS (21.1 vs 19.2mos.) while longer median time-to-deterioration of EORTC QLQ-C30 in the exploratory analyses of QoL & the safety profile was consistent with prior reported studies without new or unexpected safety signals. The results were published in the Lancet Respiratory Medicine
Ref: PRNewswire | Image: Innovent
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
