On May 14, 2025, the US Food and Drug Administration (FDA) announced the approval of telisotuzumab vedotin-tllv (EMRELIS™) to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with high levels of c-Met protein who have been previously treated with a systemic therapy, such as immunotherapy or chemotherapy.
This ADC, or antibody-drug conjugate, is the first approval of its kind. This ADC treatment is designed with two key elements.
- One part of the treatment binds specifically to the overexpressed c-Met protein on the surface of cancer cells.
- The other part of the treatment carries an important payload—a drug that specifically targets and kills the cell.
The FDA approval is supported by data from the phase 2 LUMINOSITY trial, which included 84 patients who had wildtype (unmutated) EGFR genes and non-squamous NSCLC with high c-Met protein levels. The study showed that 35% of patients had their cancer shrink or disappear with this treatment (overall response rate), and this response to treatment lasted approximately 7.2 months (median duration of response).
It’s important to note that this is an accelerated approval intended to bring treatments to patients as quickly as possible. This drug continues to be tested, with a phase 3 clinical trial called TeliMET NSCLC-01 now open for enrollment.
For more details, including common side effects, please see the FDA press release.
Learn more about the accelerated FDA approval process.