Fda approval for teliso-v

AbbVie's Teliso-V, an investigational antibody-drug conjugate (ADC) targeting c-Met protein overexpressing non-small cell lung cancer (NSCLC) patients, has been the subject of FDA interactions and approvals. Here's a summary of the key events:

1. Breakthrough Therapy Designation: In December 2021, Teliso-V was granted Breakthrough Therapy Designation by the FDA for the treatment of NSCLC with c-Met overexpression.
2. Biologics License Application (BLA) Submission: On September 27, 2024, AbbVie submitted a BLA to the FDA for accelerated approval of Teliso-V in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous NSCLC with c-Met protein overexpression.
3. FDA Review: The BLA submission is supported by data from the Phase 2 LUMINOSITY trial (M14-239), which showed meaningful response rates and other clinically relevant outcomes in patients with c-Met protein overexpressing NSCLC. The FDA's Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program will conduct the review of the BLA.
4. Potential Approval: If approved, Teliso-V would be the first-in-class therapy for c-Met overexpressing NSCLC patients, who currently have limited treatment options.

The FDA approval process for Teliso-V is underway, with the BLA submission supported by promising clinical trial data. The potential for Teliso-V to become a new treatment option for NSCLC patients with c-Met overexpression is an important development in the field of lung cancer treatment.