AbbVie Seeks the US FDA’s Accelerated Approval of Telisotuzumab Vedotin (Teliso-V) for Treating Non-Squamous NSCLC
Shots:
- AbbVie has submitted BLA seeking the US FDA’s accelerated approval of Teliso-V in treatment-experienced patients with locally advanced or metastatic EGFR wild type, c-Met overexpressing, non-squamous NSCLC. Teliso-V alone is also under P-III (TeliMET NSCLC-01) confirmatory trial evaluation, with global enrollment underway
- The BLA was supported by an ongoing P-II (LUMINOSITY) study assessing the safety & efficacy of Teliso-V alone as 2L or 3L settings to treat c-Met overexpressing NSCLC. Recent data was highlighted at ASCO 2024
- Topline data, shared in 2023, showed an ORR (as per ICR) of 35% & 23%, mDoR of 9mos. & 7.2mos. as well as mOS of 14.6mos. & 14.2mos. among c-Met High & c-Met Intermediate patients, respectively
Ref: AbbVie | Image: AbbVie
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
