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telisotuzumab

Generic: telisotuzumab·Brand: Emrelis

telisotuzumab: developed by 1 company · 3 clinical trials tracked · 1 FDA decision.

telisotuzumab evidence translation

What we can confirm

1 FDA record · 3 tracked trials

What it means

Source-backed records connect telisotuzumab to ABBV; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could telisotuzumab → ABBV affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Non-Small Cell Lung Cancer

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
AbbVie Inc. (ABBV)Approved
Clinical Trials (3)

Expanded Access to Telisotuzumab Vedotin

NCT04830202·N/A·ABBV
Available
Expanded AccessAbbVie

A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

NCT06568939·Phase 2·ABBV
Recruiting

Primary endpoint: Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)

InterventionalRandomizedopen150 targetStarted 2025-01Completion 2028-0250 sites · Brazil, China, United StatesAbbVie

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

NCT04928846·Phase 3·ABBV
Recruiting

Primary endpoint: Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)

InterventionalRandomizedopen768 targetStarted 2022-03Completion 2029-0250 sites · United StatesAbbVie
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )(ABBV)FDA ↗
BLA761384Type 1 - New Molecular EntityPriority ReviewPriorityOtherVial

Frequently asked questions

Who is developing telisotuzumab?

telisotuzumab is being developed by AbbVie Inc..

How many clinical trials involve telisotuzumab?

BioSniper tracks 3 clinical trials involving telisotuzumab.

What is telisotuzumab's latest FDA decision?

The most recent tracked FDA decision for telisotuzumab is Approval for 1 INDICATIONS AND USAGE EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 ), dated May 14, 2025.