BRAZIL · HEALTH
Key Facts
- —What is happening Brazil’s regulator Anvisa approved Emrelis for advanced lung cancer, with the gazette entry on Monday, 19 October, and a breast cancer drug, Poherdy, is said to be approved too.
- —Why it matters Emrelis, from US drugmaker AbbVie, reportedly makes Brazil the second country to approve it, and Poherdy widens options for a common breast cancer.
- —The numbers In AbbVie’s phase 2 trial, 34.5% of lung cancer patients with high c-Met levels responded, for a median 7.2 months. Brazil expects 35,380 new lung cancer cases a year in 2026 to 2028.
- —Who is who Anvisa is Brazil’s national health regulator. AbbVie is a US pharmaceutical company, and HER2-positive breast cancer is a type driven by the HER2 protein.
- —What to watch The price still has to be set by Brazil’s drug price board CMED, and no sales date is confirmed. Public health system coverage needs a separate review.
- —Power Index Brazil ranks 1st of 14 in The Rio Times Latin America Power Index, with 75.0 points (October 2026 edition).
- —What it means for you US residents in Brazil with these cancers should ask their oncologist about access, since price, launch date and public health system coverage are all still open.
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Brazil has approved a new lung cancer drug from a US company, and media report a breast cancer drug too. Price and launch dates are still open.
Brazil’s regulator Anvisa approved Emrelis for lung cancer and Poherdy for breast cancer, Hoje em Dia reported on 21 October. Emrelis is made by US drugmaker AbbVie.
Brazil is the second country to approve Emrelis, after the United States, O Antagonista reported. Americans live, retire and travel in Brazil, and both drugs treat common cancers.
What Anvisa Approved for Lung Cancer
Emrelis (telisotuzumab vedotin) is for adults with non-squamous non-small cell lung cancer that is locally advanced or has spread. The tumour must show high levels of a protein called c-Met, and the patient must already have had treatment, Metrópoles reported.
Anvisa’s resolution was published in the Diário Oficial da União, the federal gazette, on Monday, 19 October, according to Metrópoles. The same outlet says the registration was granted on Friday, 16 October, and runs until October 2029.
The drug joins an antibody to a cell-killing compound that the antibody carries to cancer cells with c-Met. It is given by infusion every two weeks, and a tissue test must first confirm high c-Met levels.
AbbVie won accelerated approval in the United States in May 2025, Juruá Informativo reported. Brazil is the second country to approve it, according to O Antagonista.
What the Trial Shows
The approval rests on the phase 2 LUMINOSITY study, which AbbVie funded and which had no comparison group. With high c-Met levels, 34.5% of patients saw tumours shrink, and responses lasted a median 7.2 months, Afya and O Antagonista reported.
Afya says median survival in that group was 14.3 months. Because there was no comparison arm, the study cannot show that Emrelis beats existing treatments.
Afya lists nerve damage in the hands and feet as the most common serious side effect, in 30.8% of patients. It also reports lung inflammation in 10.5% and interstitial lung disease in 9.9%, including three deaths.
Anvisa signed a commitment agreement requiring AbbVie to send more data, Afya and O Antagonista reported. About 35,380 new lung cancer cases a year are expected in Brazil in 2026 to 2028, the national cancer institute INCA estimates.
What Anvisa Approved for Breast Cancer
Poherdy treats HER2-positive breast cancer, driven by a protein called HER2, in early and metastatic disease, Hoje em Dia reported. In metastatic disease it is used with trastuzumab and docetaxel in patients with no earlier anti-HER2 treatment or chemotherapy.
In early disease it can go with trastuzumab and chemotherapy before or after surgery, especially when recurrence risk is high. The article gives no manufacturer, price or approval date for Poherdy.
Poherdy is also the brand name of a pertuzumab biosimilar from Shanghai Henlius Biotech, sold by Organon. The US Food and Drug Administration approved it as the first pertuzumab biosimilar, the companies announced on Monday, 17 November 2025.
The European Commission approved Poherdy in April 2026, the companies said. No Brazilian source found links the Brazilian approval to that product, so the connection is not confirmed.
What It Means for US Readers
US residents in Brazil with lung or breast cancer should ask their oncologist whether either drug fits their case. Neither has a price or a launch date yet, so access is not immediate.
Investors in AbbVie or Organon should note that no sales figures or prices were published for Brazil. Registration does not mean public health system coverage, which needs a separate review, Afya reported.
Related background is in the guide to healthcare for foreigners in Brazil and the report on Anvisa clearing malaria vaccine trials. See also the explainer on Brazil’s education and healthcare and the Brazil news hub.
What Is Not Known
Anvisa’s own notice and the gazette text could not be opened, so the approvals rest on Brazilian media reports. Only Hoje em Dia reported the Poherdy approval among the sources found.
Outlets differ on the date, with some saying Anvisa approved Emrelis on Monday, 19 October and Metrópoles citing Friday, 16 October. Trial figures also differ slightly between outlets, so the figures here follow Afya and O Antagonista.
The price, to be set by CMED, and the sales start are not confirmed. Juruá Informativo reports that AbbVie expects the first half of 2027, which other outlets did not confirm.
What Comes Next
CMED must set a price for Emrelis before it can be sold, and AbbVie must send Anvisa further data. Afya says registration does not automatically bring coverage by the public health system, which is decided separately.
Frequently Asked Questions
What did Anvisa approve?
Anvisa approved Emrelis for advanced lung cancer and Poherdy for HER2-positive breast cancer. Hoje em Dia reported both approvals on Wednesday, 21 October.
What is Emrelis used for?
Emrelis (telisotuzumab vedotin) treats adults with locally advanced or metastatic non-squamous non-small cell lung cancer with high c-Met levels. Patients must have had earlier treatment and a test that measures c-Met.
What is Poherdy used for?
Poherdy is for HER2-positive breast cancer, both early and metastatic, and is given with trastuzumab. In metastatic disease it is also combined with docetaxel.
Is Emrelis a cure?
No. The trial had no comparison group, so it cannot show Emrelis beats existing treatments. Anvisa wants more data.
When will the drugs be sold in Brazil?
No launch date is confirmed for either drug. Emrelis needs a price from the CMED board, and public health system coverage needs a separate review.
Sources: Hoje em Dia, 21 October; Metrópoles, 21 October; O Antagonista; Afya, 19 October; Juruá Informativo; Henlius and Organon, 17 November 2025; Henlius and Organon, European Commission approval (all accessed 22 October 2026).
This article was produced by The Rio Times’ automated newsroom system. How we use AI · Report an error · Editorial responsibility: Matthias Camenzind, Editor-in-Chief