🇧🇷 Cancer in Brazil

INCA's first Estimativa appeared in 1995, and it describes its current method as analogous to the one IARC uses for GLOBOCAN; the main inputs are the population-based cancer registries (Registros de Câncer de Base Populacional, RCBP) and the national mortality information system (SIM). Where a state or capital has consolidated registry data, short-term prediction models are fitted; elsewhere INCA applies the registry's incidence-to-mortality ratio, or the median ratio of its region, to modelled 2026 mortality. The 2026 to 2028 edition, launched on World Cancer Day, 4 February 2026, applies corrections for under-registration of both deaths and cases, and INCA states that its editions should not be compared directly as a time series, because better data and revised methods move the numbers. Non-melanoma skin cancer is estimated at 263,280 new cases a year (136,180 in men, 127,100 in women) and is presented separately because of its high incidence and low lethality.

INCA's Estimativa 2026 gives, for each year of 2026 to 2028: breast 78,610 (71.57 per 100,000 women); prostate 77,920 (74.62 per 100,000 men); colon and rectum 53,810 (26,270 in men, 27,540 in women); trachea, bronchus and lung 35,380 (18,730 and 16,650); stomach 22,530 (13,830 and 8,700); cervix 19,310 (17.59 per 100,000 women); oral cavity 17,190 (12,260 and 4,930); thyroid 16,450 (3,140 and 13,310). INCA's news release lists the five commonest in men as prostate, colorectum, lung, stomach and oral cavity, and in women as breast, colorectum, cervix, lung and thyroid. The country is uneven: estimated breast cancer risk is 88.29 per 100,000 women in the Southeast and 31.28 in the North, and prostate 94.90 per 100,000 men in the Southeast against 29.94 in the North. INCA also expects 7,560 cancers a year in children and adolescents.

Deaths in 2023 from the mortality system, as quoted in the Estimativa: trachea, bronchus and lung 31,237 (16,758 men, 14,479 women); colon and rectum 23,953; female breast 20,165 (18.59 per 100,000 women); prostate 17,258 (16.71 per 100,000 men); stomach 14,823; pancreas 13,507 against 13,240 expected new cases a year; liver 11,199 against 12,350; central nervous system 10,206; oesophagus 8,488; leukaemia 7,435; cervix 7,209; oral cavity, salivary glands and oropharynx 7,172. INCA's statistics page gives 120,784 cancer deaths in men and 110,910 in women in 2021, 231,694 in all, with prostate the leading cause in men (16,300) and breast in women (18,139). Brazil publishes no national survival series; OnCo names that gap below rather than borrowing a figure.

Article 196 of the 1988 Federal Constitution reads that health is a right of all and a duty of the state, guaranteed through universal and equal access. Law 12.732 of 22 November 2012, Article 1, states that a patient with a malignant neoplasm will receive, free of charge in the SUS, all necessary treatments, and that the standard cancer therapies must be revised and republished as science and new proven treatments require; Article 2, paragraph 2, gives people in pain from cancer privileged free access to opioid analgesics. Cancer care in the SUS is delivered in hospitals accredited as UNACON or CACON (high-complexity oncology units and centres) under Portaria SAES/MS 1399 of 17 December 2019, and state and municipal health departments decide where each patient is referred. Law 14.758 of 19 December 2023 created the National Cancer Prevention and Control Policy and a national programme of patient navigation for people diagnosed with cancer; it was amended by Law 15.385 of 10 April 2026.

ANS counts 53,055,406 people in medical plans in June 2026, 38,767,278 of them in employer group plans, and puts coverage at 24.9 per cent of the population in August 2026, up from 22.5 per cent in December 2016. The Rol de Procedimentos e Eventos em Saúde, set by Normative Resolution 465 of 2021, is updated continuously: proposals are assessed on evidence, comparative economic evaluation and budget impact, discussed by the Cosaúde committee and put to public consultation before ANS's board decides. Technologies the SUS incorporates on CONITEC's recommendation enter the list within 60 days. ANS's page notes that the Health Plans Law excludes oral medicines unless they are for cancer. Law 14.454 of 21 September 2022 amended the Health Plans Law to set criteria for cover beyond the list; one is a recommendation by CONITEC or by at least one internationally renowned health technology assessment body, a term the law does not define.

The Ministry's announcement, republished by INCA on 21 May 2026, describes an investment of R$2.2 billion in a new SUS funding table covering 23 high-cost oncology medicines for 25 types of cancer, including breast, lung, leukaemia, ovary and stomach, a 35 per cent increase in the medicines offered, which the Ministry says benefits 112,000 patients. Ten are bought centrally by the Ministry and distributed to the states; the rest are bought by the accredited cancer centres and reimbursed through the outpatient procedure authorisation (APAC) with a national price agreement. The same package funded robotic cancer surgery in the public network for the first time and widened access to breast reconstruction. The measures sit under the Pharmaceutical Assistance in Oncology component (AF-Onco). The AMAZONA III cohort showed the consequences of a two-track system for one cancer: women with breast cancer treated in the public system were diagnosed at stage III more than twice as often as privately insured women (33.5 against 14.7 per cent).

Article 2-A of Law 12.732, added by Provisional Measure 1.301 of 30 May 2025 and converted into Law 15.233 of 7 October 2025, creates within the Agora Tem Especialistas programme a set of actions to widen access to radiotherapy: shorten waiting times, integrate the Ministry's information systems, and prioritise cancer patients through monitoring panels that join up demand and supply across public and private services. Every establishment with radiotherapy equipment must report supply and demand periodically, and one that fails to report loses access to the Pronon programme, the SUS Radiotherapy Expansion Plan and federal financing until it does. Patients having radiotherapy in a different federative entity (municipality, state or Federal District) from the one where they live are guaranteed transport and daily allowances for the whole treatment, subject to specific budget availability.

CONITEC's page sets out the legal framework: a decision deadline of 180 days, extendable by 90; an analysis based on scientific evidence of efficacy, accuracy, effectiveness and safety and on a comparative economic evaluation of benefits and costs against technologies already available; and prior registration with ANVISA. Its judicial guidance adds the conditions of Decree 7.646/2011: a proponent, ANVISA registration, price regulation by the medicines market chamber CMED, and evidence that the technology is at least as effective and safe as those already in the SUS for the indication. The commission works in three committees (medicines; products and procedures; clinical protocols), each with 17 voting institutions; the National Council of Justice, the National Council of the Public Prosecutor's Office and the public defenders' council take part without a vote. Public consultations carry a plain-language report for society, and patients can testify about the condition and the technology. In May 2026, for example, CONITEC consulted on pembrolizumab before and after surgery for high-risk early triple-negative breast cancer.

CONITEC's judicialisation page lists the Supreme Federal Court's conditions for a court order to supply a medicine outside the SUS lists: (1) the medicine was refused by the responsible public body; (2) CONITEC's decision not to include it was unlawful, no request for inclusion was made, or the analysis was excessively delayed; (3) no other medicine on the SUS lists can replace it; (4) there is scientific evidence it is effective and safe; (5) it is indispensable to treat the disease; (6) the person cannot afford it. The page exists to give judges and prosecutors the status of any technology under assessment. OnCo could not source a current national count of cancer-medicine lawsuits from an official page.

ANS's rite for SUS-incorporated technologies checks only whether the technology is already listed and whether it conflicts with the Health Plans Law, such as the exclusion of non-cancer oral medicines, before adding it within 60 days of the incorporation order. Its own updates through FormRol follow the full evidence, economic evaluation and budget-impact path with public consultation. Law 14.454/2022 sets criteria for cover beyond the list, including a recommendation by CONITEC or an internationally renowned assessment body. OnCo did not verify from an official source how the courts have since read that law, and names it as a gap.

The federal services page for medicine registration gives the deadlines: priority category 120 days counted from the date of prioritisation; ordinary category 365 days from the filing of the registration request; in both, a single extension of up to one third, by reasoned decision. A registration is normally valid for ten years; one granted under a commitment agreement is valid for three years at first, then five. ANVISA is a partner in the FDA's Project Orbis for concurrent review of cancer medicines alongside the regulators of Australia, Canada, Israel, Japan, Singapore, Switzerland and the United Kingdom. ANVISA does not publish an average time to approval for new cancer medicines on the pages OnCo could read; that is named as a gap.

RDC 205 of 28 December 2017 defines a rare disease as one affecting up to 65 people per 100,000 and sets the steps for registering a new rare-disease medicine: a pre-submission meeting held within 60 days of the company's request; submission within 30 days of that meeting under a specific subject code; ANVISA's assessment within 60 days of submission, ending in a request for information or a conclusive opinion; the company's reply within 30 days; and ANVISA's assessment of the reply within 45 days. Without the pre-submission meeting the application cannot use this route. The same resolution sets 120 days for good manufacturing practice certification. These are the timelines as published in 2017; OnCo did not check later amendments.

Normative Instruction 289/2024 lets ANVISA take into account the evaluation of an equivalent foreign regulatory authority (AREE) when assessing registration or post-approval changes for medicines, biological products and vaccines; ANVISA published an English version and question-and-answer guidance on regulatory reliance. RDC 997/2025, in force from 10 November 2025, set exceptional and temporary procedures to reduce the medicines backlog. From 24 February 2026 a dedicated team in ANVISA's biologics directorate began optimised assessment: of the first 13 registration requests taken from the ordinary queue, nine were accepted for the optimised route and the rest had incomplete documents. On 15 April 2026 ANVISA's board heard an action plan combining optimised analysis, reliance, risk-based prioritisation and better data management, and called the backlog one of the agency's main institutional challenges of 2026.

Law 12.732/2012, Article 2, gives a patient with a malignant neoplasm the right to a first treatment in the SUS within up to 60 days from the day the diagnosis is signed in a pathology report, or sooner as the therapeutic need recorded in the single record requires; treatment counts as started with surgery, radiotherapy or chemotherapy. Paragraph 3, added by Law 13.896 of 30 October 2019 and in force 180 days after its publication on 31 October 2019, requires the tests needed to clarify a case whose main diagnostic hypothesis is cancer to be done within 30 days of a reasoned request by the doctor. How far the system meets the ceiling has been measured for breast cancer: in the AMAZONA III cohort the median from diagnosis to first treatment was 56 days in the public system and 34 in the private, and public-system patients had 4.74 times the odds of starting after 60 days.

The hospital's own history dates it to 24 March 1962, when Paulo Prata and Scylla Duarte Prata founded a general hospital in central Barretos; people in the region then had to travel hundreds of kilometres for cancer treatment, and the small hospital began to take many of them in; it describes itself as the largest cancer complex in Latin America offering care entirely free of charge. Its current page lists eight treatment units, 23 fixed prevention units and 52 mobile units spread across Brazil, and describes this as the largest number of mobile screening and early detection units in the world, a claim OnCo reports as the hospital's own. It also hosts a branch of the IRCAD minimally invasive surgery training centre and a molecular oncology research centre.

The Hemocentro de Ribeirão Preto's academic CD19 CAR-T (HD37 clone, 4-1BB domain) treated 20 people with relapsed or refractory B-cell leukaemia or lymphoma from 2019 to 2023, reported in Bone Marrow Transplantation in 2024. The prospective phase 1/2 trial CARTHEDRALL (NCT06101381) started on 21 March 2024, aims to enrol 81 patients and runs at the Ribeirão Preto Medical School, Hospital das Clínicas de São Paulo, UNICAMP, Hospital Sírio-Libanês and A Beneficência Portuguesa de São Paulo. The centre says ANVISA chose it for a pilot project on advanced therapy products, and that its Nutera RP factory, built with the Instituto Butantan, and a São Paulo unit can treat more than 300 patients a year after more than R$200 million of investment. In October 2026 its director-president argued that treating centres across the country must be trained now for the therapy to reach SUS patients.

INCA's guidance, updated on 30 September 2025, states that from September 2025 routine mammography is recommended for women aged 50 to 74 every two years, in line with the Latin American and Caribbean Code Against Cancer, and that in other age groups and intervals the balance of benefit and harm is unfavourable; trans men and non-binary people assigned female at birth who have kept their breasts are included. For the cervix, the national guideline on organised screening with molecular tests for oncogenic HPV DNA made the HPV test the primary screening test; cytology (the Papanicolaou smear) continues where the new test is not yet offered. Screening is for people with a cervix aged 25 to 64 who have ever been sexually active.

The Ministry's national protocol, announced on 21 May 2026 and republished by INCA, sets the FIT as the reference test for asymptomatic men and women aged 50 to 75, quotes a sensitivity of 85 to 92 per cent, and expects to widen access to prevention and early detection for more than 40 million Brazilians. The kit is collected at home and analysed in a laboratory; a positive result is referred for complementary examination, with colonoscopy the reference standard. INCA estimates 53,810 new colorectal cancers a year in 2026 to 2028, the second commonest cancer in Brazil excluding non-melanoma skin cancer.

ClinicalTrials.gov lists 47 studies with LACOG as lead sponsor when OnCo checked on 3 November 2026, among them a phase 3 trial of anthracycline and taxane sequencing in locally advanced HER2-negative breast cancer (NCT04540692), phase 2 trials in lung, prostate, penile and gynaecological cancers, and epidemiological cohorts in breast, lung, cervical, renal, endometrial and neuroendocrine cancers. AMAZONA III (NCT02663973), run with the Brazilian breast cancer group GBECAM and the Ministry of Health, followed 2,950 women at 23 sites and found that only 34 per cent were diagnosed by screening. OnCo could not reach LACOG's own website, so its founding and membership are not given.

The Atlas Tumoral da População Brasileira (ATPBR) was approved in 2023 with R$8.72 million over three years under the federal Genomas Brasil programme and is coordinated at INCA by João Paulo Viola and Mariana Boroni; its rationale and design were published in The Lancet Regional Health - Americas in 2026. Its stated aim is a secure platform for storing and sharing multi-omics tumour data. Its abstract reports no counts of tumours sequenced; OnCo did not read the full text.

INCA reported on 1 June 2026 that the Ministry's science secretariat convened INCA, A.C.Camargo Cancer Center, Beneficência Portuguesa, Hospital Alemão Oswaldo Cruz, Hospital Israelita Albert Einstein, Hospital Moinhos de Vento, Hospital Sírio-Libanês, the National Center for Research in Energy and Materials, Fiocruz and the Federal University of Minas Gerais, coordinated by Hospital do Coração (HCor). The idea followed an agreement between the Ministry and the University of Oxford on cancer vaccines. The first phase is an integrated research infrastructure: a national oncology data platform that follows patients over time and a national biobank of DNA, blood, plasma and tumour tissue with clinical trial data.

International studies such as CONCORD have included Brazilian population-based registries, but they cover a minority of the population and are not an official national figure. INCA's statistics pages give incidence estimates and deaths only. A reader looking for survival for a specific cancer will find it, where it exists, on the cancer's own page, with its cohort.

The Planalto legislation site and INCA's document repository (ninho.inca.gov.br) refused connections, so laws were read from the Chamber of Deputies' and Senate's copies; the full text of Law 14.758/2023 and of its April 2026 amendment was not read, only the Senate's summary. The national all-cancer death total for 2023 was not found on an INCA page (2021 is given). CONITEC's cost-effectiveness reference value, reported in the press in 2022, could not be verified from an official document. The current number of UNACON and CACON accredited hospitals loads dynamically on INCA's page and was not captured. ANVISA's average approval times for new cancer medicines, the date ANVISA joined Project Orbis, and how the courts have interpreted Law 14.454/2022 were not verified. The share of Brazilian health spending paid out of pocket was not sourced. LACOG's own website did not respond.