BLASINGLE-DOSEVIALPriority Review
Approved
May 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EMRELIS (telisotuzumab vedotin) is a monoclonal antibody-drug conjugate (ADC) targeting DLL3, approved by the FDA in May 2025 for non-small cell lung cancer and advanced solid tumors. It represents a novel mechanism combining antibody-mediated targeting with cytotoxic payload delivery. The drug enters a competitive oncology landscape as a single-dose intravenous therapy.
Launch
Product is in early launch phase with moderate competitive pressure (30); brand team will focus on market access, payer education, and field force activation in oncology.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
Started Feb 2026
60 enrolled
Lung Non-Small Cell Carcinoma
A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Started Jan 2025
150 enrolled
Non-Small Cell Lung Cancer
Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein
Started May 2024
0Non-Small Cell Lung Cancer
A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Started Nov 2022
9 enrolled
Non Small Cell Lung Cancer
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Started Mar 2022
698 enrolled
Non Small Cell Lung Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.