Tanja Obradovic: AbbVie submitted telisotuzumab vedotin in adult NSCLC patients with tumors with EGFR non squamous histology

Tanja Obradovic shared a post on LinkedIn:

“Completely new treatment option by novel antibody-drug conjugate (ADC) may be coming with latest BLA just submitted for accelerated approval to FDA for relapsed/refractory non-small cell cancer (NSCLC) patients.

AbbVie submitted telisotuzumab vedotin (Teliso-V) in adult NSCLC patients with tumors with wild-type epidermal growth factor receptor (EGFR), non squamous histology and with cMet protein over-expression. Teliso-V is first-in-class, cMet protein directed ADC.

This comes after Teliso-V received Breakthrough Therapy Designation by the FDA in 2021. BLA submission is supported by data from Phase 2 LUMINOSITY trial and data is evaluated under Real-Time Oncology Review (RTOR) program so good news for patients may come soon.

Important to note is that in addition to this BLA resulting from Phase 2 results global confirmatory Phase 3 is already open and enrolling relapsed/refractory NSCLC patients with cMet over-expression (TeliMET NSCLC-01).

Additional information

Source: Tanja Obradovic/LinkedIn

Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.