Your oncologist may have a new option to treat HER2-positive breast cancer — the type that affects 20% of patients and has more aggressive behavior. The National Health Surveillance Agency (Anvisa) approved on Monday (18) a new indication for Enhertu (trastuzumab deruxtecan), allowing use in combination with pertuzumab as first-line treatment for unresectable or metastatic tumors. ✓
Press quotes (2)
"A Agência Nacional de Vigilância Sanitária (Anvisa) aprovou, nesta segunda-feira (18) uma nova indicação terapêutica para o medicamento Enhertu (trastuzumabe deruxtecana)."
"O HER2positivo representa aproximadamente 20% dos casos de câncer de mama e está associado a um comportamento clínico mais agressivo"
Enhertu was already registered in Brazil for breast cancer, but can now be used specifically in patients with HER2-positive (IHC 3+ or ISH+) — cases where the tumor cannot be completely removed by surgery or when the disease has spread to other parts of the body. The approval was based on a study that demonstrated clinically relevant and statistically significant improvement in progression-free survival, according to Anvisa. ✓
Press quotes (2)
"o medicamento passa a ser usado em combinação com o pertuzumabe para o tratamento de primeira linha de pacientes com câncer de mama HER2positivo (IHC 3+ ou ISH+)"
"De acordo com a Anvisa, a nova indicação foi fundamenta em estudo que demonstrou melhora clinicamente relevante e estatisticamente significativa na sobrevida livre de progressão."
The current standard treatment for these cases is the combination of chemotherapy with taxanes (docetaxel or paclitaxel) associated with trastuzumab and pertuzumab, which achieves median progression-free survival of 18.7 months. But taxane side effects, especially peripheral neuropathy, have been a limiting factor for prolonged use, according to analysis by the Brazilian Society of Clinical Oncology (SBOC). The drug is manufactured by Daiichi Sankyo in partnership with AstraZeneca. ✓
Press quotes (2)
"O tratamento padrão para o câncer de mama avançado/metastático HER2 positivo em primeira linha corresponde à combinação de quimioterapia com taxano (docetaxel ou paclitaxel) associado a trastuzumabe e pertuzumabe"
"Todavia, os efeitos colaterais dos taxanos têm reduzido a qualidade de vida das pacientes. A toxicidade cumulativa, especialmente a neuropatia periférica, tem sido fator limitador para uso o uso prolongado desta droga."
Approval was based on study demonstrating improvement in progression-free survival
HER2-positive cancer represents 20% of cases and has more aggressive behavior
Covered by only some sources, or where the accounts diverge.
Covered by only some sources (1)
Approval documented in Resolution RE No. 1.991, of May 14, 2026
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What was the specific efficacy of Enhertu in combination with pertuzumab in the study that supported the approval?
Why it's still unknown: Anvisa mentioned improvement in progression-free survival, but did not disclose specific numerical data from the study
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When will Enhertu with the new indication be available to patients in Brazil?
Why it's still unknown: No source reported timeline for availability of the new indication
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Is there a prospect of incorporating the new indication into SUS?
Why it's still unknown: The drug had not been analyzed by Conitec until November 2024, and there is no information about evaluation of the new indication