Brazil's ANVISA News - Dupixent approved for allergic fungal rhinosinusitis, Enhertu for mBC | iPharmaCenter
- Badari Andukuri
- May 27
- 2 min read
Dupixent Approved in Brazil for Allergic Fungal Rhinosinusitis in Patients Aged 6 and Older
Brazil’s health regulator ANVISA has cleared Dupixent (dupilumab) for use in adults and children aged 6 years and above with allergic fungal rhinosinusitis, expanding the medicine’s role in managing this difficult chronic sinus disorder.
What is Dupixent's mechanism of action?
Dupixent (dupilumab) works by blocking IL-4 and IL-13 signaling through the IL-4 receptor alpha subunit, helping reduce the type 2 inflammatory activity linked to this disease.
Allergic fungal rhinosinusitis is a persistent inflammatory condition of the paranasal sinuses driven by an abnormal immune response to fungal colonization, and it is commonly associated with nasal polyps, thick eosinophilic mucus, recurrent disease, and in some cases structural damage such as bone erosion. Because patients often need repeated surgery and repeated courses of systemic steroids, the condition can place a major burden on daily life, especially in younger patients.
The approval was supported mainly by data from the Phase 3 AIMS study, which evaluated dupilumab in affected patients and showed meaningful improvement across radiologic findings, endoscopic measures, symptoms, smell function, and quality of life. The treatment also lowered the need for systemic corticosteroids and sinonasal surgery, while its safety profile remained in line with the established experience seen in earlier approved uses of the drug.
Use in children aged 6 years and older was supported through pharmacokinetic and clinical pharmacology analyses, together with prior pediatric experience in approved indications such as atopic dermatitis and asthma. This broader pediatric evidence helped reinforce confidence in the medicine’s benefit-risk profile for younger AFRS patients.
Enhertu Approved With Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer
ANVISA has also approved Enhertu (trastuzumab deruxtecan) in combination with pertuzumab as a first-line option for adults with unresectable or metastatic HER2-positive breast cancer.
What is the mechanism of action of Enhertu?
Enhertu is an antibody-drug conjugate that combines HER2-targeted antibody delivery with a topoisomerase I inhibitor payload, allowing targeted destruction of tumor cells that overexpress HER2.
HER2-positive disease represents about 20% of breast cancer cases and is known for a more aggressive clinical course, faster progression, and poorer outcomes in advanced settings. Although treatment progress has improved patient outcomes over time, metastatic HER2-positive breast cancer remains a serious and still incurable disease area.
The expanded indication was primarily backed by results from the Phase 3 DESTINY-Breast09 trial, which compared Enhertu plus pertuzumab with the standard taxane, trastuzumab, and pertuzumab regimen. The study reported median progression-free survival of 40.7 months for the ENHERTU combination versus 26.9 months for the comparator arm, equal to a 44% reduction in the risk of progression or death, with a hazard ratio of 0.56.
The trial also showed stronger response rates and longer durability of response in the Enhertu-containing arm. Safety findings were consistent with the known profiles of Enhertu and pertuzumab, and no unexpected new risks were identified during the evaluation.
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