The National Health Surveillance Agency (Anvisa) granted approval on Monday, the 19th, for the drug telisotuzumab vedotin, sold under the trade name Emrelis. This drug is intended for adults with non-small cell lung cancer (NSCLC) in advanced or metastatic stages. With this decision, Brazil has reached the position of the second country to authorize the treatment, trailing only the United States, where the product received accelerated approval in May 2025.
This medication was developed by the American pharmaceutical company AbbVie and is specifically indicated for patients with non-squamous tumors that show high expression of the c-Met protein and who have already undergone some prior systemic treatment. The detection of this biomarker is crucial for determining which patients may benefit from this therapy.
The Brazilian approval was based on the results of the Phase 2 clinical study named LUMINOSITY. In this research, an objective response rate of 34.6% was observed among patients who showed high c-Met expression. It is important to note that this percentage indicates a measurable reduction in the tumor, not that the participants were completely cured.
The LUMINOSITY study evaluated the drug in individuals with advanced or metastatic lung cancer who had already received previous treatments. Among participants with high c-Met expression, the objective response rate reached 34.6%, while in the group with intermediate protein expression, this index was lower, totaling 22.9%. When considering patients with increased c-Met expression in the primary analysis, the overall objective response rate was 28.6%.
Objective response refers to the proportion of patients who experienced a significant tumor reduction, according to established medical criteria. The results obtained do not equate to a cure rate nor do they imply, in isolation, that disease progression has ceased in all patients.
For patients with high c-Met expression who responded to the treatment, the median duration of this response was nine months, according to the study's published analysis. The most frequently reported side effects included fatigue, peripheral edema, decreased appetite, and peripheral neuropathy, the latter potentially causing sensations such as numbness, tingling, or pain in the extremities.
In the United States, the Food and Drug Administration (FDA) granted accelerated approval to Emrelis in May 2025, based on the objective response rate and the duration of responses. The US agency emphasized that the maintenance of this approval may be conditional upon confirming clinical benefit in subsequent research.
Despite the registration authorization by Anvisa, the drug will not be immediately available in Brazilian pharmacies or hospitals. The next phase requires evaluation and price determination by the Drugs Market Regulation Chamber (CMED). Only after the completion of this procedure can the product be marketed in the national territory.
According to AbbVie, the expectation is that all necessary steps for entry into the Brazilian market will be finalized in the first half of 2027. Furthermore, regulatory approval does not guarantee the immediate availability of Emrelis through the Unified Health System (SUS). For the therapy to be integrated into the public network, a specific health technology assessment process conducted by the National Commission for the Incorporation of Technologies into the Unified Health System (Conitec) is essential.
Globally, lung cancer is among the tumors that cause the most deaths worldwide. International estimates for 2024 point to about 2.65 million new diagnoses and over 1.8 million deaths. In Brazil, the National Cancer Institute (Inca) projects 35,380 new annual cases of tracheal, bronchial, and lung cancer for each year of the 2026 to 2028 triennium, covering both sexes.
Smoking is identified as the main risk factor for the disease, although other elements, such as exposure to air pollution and certain substances in the workplace, are also associated.
The release of Emrelis expands treatment alternatives for a specific group of patients with advanced lung cancer, with the potential benefit depending on the characteristics of the tumor, the identification of the c-Met protein, and each patient's individual treatment history.