Telisotuzumab vedotin fda
WebJan 5, 2024 · The FDA has granted a breakthrough therapy designation to telisotuzumab vedotin (ABBV-399; teliso-V) for use in patients with advanced or metastatic EGFR … WebApr 5, 2024 · Brief Summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving …
Telisotuzumab vedotin fda
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WebAmivantamab - Wikipedia WebThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to AbbVie’s telisotuzumab vedotin (Teliso-V) to treat nonsquamous non-small cell lung cancer (NSCLC). AbbVie Corporate Headquarters. …
WebJan 4, 2024 · The FDA's BTD program is intended to expedite the development and review of medicines with preliminary clinical evidence that indicate that the investigational treatment may demonstrate ... Webtelisotuzumab vedotin, also known as ABBV-399, is a cancer drug with 2 actively recruiting clinical trials and 1 FDA/NCCN therapies. Cancer Search Home; ... FDA Breakthrough Therapy 62807 2024-01-04 Show 1 Therapies for telisotuzumab vedotin Main Menu. Clinical Trials. Therapies. Biomarkers ...
WebJun 2, 2024 · 9016 Background: Teliso-V is an antibody-drug conjugate composed of a c-Met antibody (ABT-700) and a microtubule inhibitor (monomethyl auristatin E). The phase 2 M14-239 trial (LUMINOSITY, NCT03539536) aims to identify the c-Met OE NSCLC populations best suited to Teliso-V (Stage 1) and expand selected groups for further … WebNov 4, 2024 · The use of telisotuzumab vedotin (ABBV-399) plus erlotinib (Tarceva) for patients with c-MET protein expressing non–small cell lung cancer (NSCLC) showed promising antitumor activity, according to results published in the Journal of Clinical Oncology. 1. Findings from a phase 1/1b study multicenter, open-label study …
WebOct 4, 2024 · Purpose This first-in-human study evaluated telisotuzumab vedotin (Teliso-V), formerly called ABBV-399, an antibody–drug conjugate of the anti–c-Met monoclonal antibody ABT-700 and monomethyl auristatin E. Materials and Methods For dose escalation, three to six patients with advanced solid tumors were enrolled in eight cohorts (0.15 to …
WebNov 1, 2024 · Purpose: Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate. Here, we present safety and efficacy data from a phase I/Ib study of Teliso-V monotherapy evaluated in once every 2 weeks/once every 3 weeks schedules in patients with non-small cell lung cancer (NSCLC). oggi stainless steel thermal carafesWebEach group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting ... oggi the turningpointWebMar 1, 2024 · Telisotuzumab vedotin is an anti-MET ADC targeting MET-overexpressing solid tumors. It has an anti-MET antibody linked to MMAE with a DAR of 3.1. Telisotuzumab vedotin delivers MMAE to the tumor cells via the MET receptor directly. It has shown activity in both c-MET-amplified and MET-overexpressing tumor cells in mouse xenograft … oggi switch off