Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that c-Met >= 50% status confers therapeutic sensitivity to Telisotuzumab Vedotin in patients with Lung Non-Squamous Non-Small Cell Carcinoma.

The U.S. Food and Drug Administration (FDA) granted accelerated approval to telisotuzumab vedotin, a c-Met-directed antibody and microtubule inhibitor conjugate, 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. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

Citation

Abbvie Inc. Emrelis (telisotuzumab vedotin-tllv) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761384s000lbl.pdf. Revised May 2025. Accessed June 12, 2025. Abbvie Inc. Emrelis (telisotuzumab vedotin-tllv) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761384s000lbl.pdf. Revised May 2025. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2025-06-12	Van Allen lab	The FDA provided regular approval to taletrectinib for the treatment of patients with ROS1 positive non-small cell lung cancer, accelerated approval to telisotuzumab vedotin-tllv for the treatment of patients with non-squamous non-small cell lung cancer with high c-Met expression, and avutometinib in combination with defactinib (Avmapki Fakzynja co-pack) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer.
2025-05-14	Food and Drug Administration	Indication received accelerated approval.