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Registration of oral medication against advanced breast cancer draws attention for addressing a specific patient profile, with ESR1 mutation and previous endocrine treatment, amid the update of national data on the incidence of the disease in Brazil.
The National Health Surveillance Agency approved the registration of Inluriyo® (inlunestrant tosylate), an oral medication indicated for adults with locally advanced or metastatic breast cancer, in cases with ESR1 mutation and a history of endocrine treatment.
Published on June 22, 2026, the decision applies to patients with estrogen receptor-positive tumors, negative for human epidermal growth factor receptor 2, and with a mutation in estrogen receptor 1.
In clinical practice, this profile is usually identified by the acronyms ER+, HER2-, and ESR1m, used to classify the molecular characteristics of cancer and guide therapeutic choices according to the stage of the disease and treatments already performed.
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Developed by Eli Lilly do Brasil Ltda., the medication was registered as monotherapy, meaning it is to be used without mandatory combination with another drug within the indication approved by the Brazilian regulatory agency.
New treatment for advanced breast cancer
Aimed at a specific group of patients, Inluriyo® does not apply to all breast cancer diagnoses, as the authorization only covers locally advanced or metastatic tumors with the characteristics defined by Anvisa.
The indication includes cases where the tumor cannot be removed by surgery or has already spread to other parts of the body, a situation that requires specialized monitoring and therapeutic decisions based on exams and clinical history.
This distinction is important because breast cancer comprises different subtypes, and each of them may respond differently to available treatments, depending on hormonal, molecular factors, and the progression of the disease.
Among the required criteria, the ESR1 mutation appears as a central element for patient classification, alongside estrogen receptor positivity and the absence of HER2 expression in tumor classification.
Besides defining the eligible audience, this information helps medical teams choose strategies more compatible with the biological profile of the disease, without turning the health registration into a promise of cure or universal solution.
The approval allows the medication to be regulated in the country for the purpose described by Anvisa, but the decision to use it still depends on a medical prescription, individual evaluation, and criteria established in the approved leaflet.
For whom Inluriyo® was approved
The group covered by the decision includes adults with advanced or metastatic breast cancer, ER+, HER2- and ESR1m, who have previously received endocrine therapy and fit the indication defined by the agency.
Formalized by Resolution 2.465/2026, the registration also highlights the use as monotherapy and the oral presentation of the product, a feature that differentiates it from therapies administered intravenously or by injection in other oncological contexts.
Even with the oral form, the treatment does not dispense with specialized monitoring, as the choice of any cancer therapy depends on the progression of the disease, laboratory tests, previous treatments, and the patient’s clinical condition.
According to Anvisa, the indication involves tumors that cannot be removed by surgery or that have already spread to other regions of the body, a condition generally associated with greater complexity in oncological care.
In this scenario, the therapeutic objective is usually related to controlling the progression of the disease and defining individualized approaches, always according to medical evaluation and technical parameters recognized by health authorities.
Breast cancer data in Brazil
Among the main public health challenges in the country, breast cancer continues with high incidence and requires permanent policies for diagnosis, treatment, and monitoring, especially in light of the update of national estimates.
In the current projection of the National Cancer Institute for the triennium 2026 to 2028, Brazil is expected to register 78,610 new cases of female breast cancer per year, according to the most recent national estimate.
This data updates the reference used between 2023 and 2025, when the estimate was 73,610 new cases per year, a number that does not represent women already cumulatively affected, but an annual projection of new diagnoses.
The difference between the estimates reinforces the need for precision in reading the numbers, because annual incidence projections should not be presented as the total number of patients affected throughout the entire analyzed period.
In the current version, INCA reports that it adopted methodological adjustments to correct under-reporting of mortality and incidence, with the aim of making the results more accurate and more representative of the Brazilian reality.
With this survey, managers and health professionals now have updated parameters to plan cancer control actions, organize care networks, and size prevention and assistance strategies.
The update of the data does not change the main fact of the news: the registration of Inluriyo® creates an authorized therapeutic option for a specific molecular profile of advanced or metastatic breast cancer.
ESR1 Mutation and Previous Endocrine Therapy
Related to estrogen receptor 1, the ESR1 mutation is part of the criteria used to define the target audience for approval and needs to be identified for the patient to be included in the indication authorized by Anvisa.
There is also a requirement linked to therapeutic history, as the medication was approved for adults who have previously received endocrine therapy, and not as a first option for any breast cancer diagnosis.
This condition prevents overly broad interpretations of the scope of the decision, as the registration does not make the medication an indicated treatment for all subtypes of the disease nor does it replace protocols defined according to medical evaluation.
With the authorization, Inluriyo® becomes part of the set of medications with sanitary registration in the country for a specific population within advanced breast cancer, marked by well-defined molecular characteristics.
The available public information confirms the regulatory approval of an oral option for cases with ER+, HER2-, and ESR1m, but does not support the claim that breast cancer is about to be eliminated in Brazil.
The treatment of the disease continues to require proper diagnosis, specialized follow-up, and therapeutic definition according to the stage, tumor profile, and history of each patient, while Anvisa’s decision expands the authorized repertoire for specific cases.
