The CAR-T therapy produced by Fiocruz will target patients with leukemia, lymphoma, and myeloma, according to Agência Brasil. The treatment removes patient defense cells, genetically modifies them in a laboratory, and reintroduces them "reprogrammed" to fight cancer. The initiative is part of the Program for Expansion and Modernization of Health Economic-Industrial Complex Infrastructure (PDCEIS), linked to the New PAC, which has already invested R$ 330 million.
Press quotes (1)
"O Sistema Único de Saúde (SUS) ganhou um reforço, neste sábado (23), com o lançamento, na Fundação Oswaldo Cruz (Fiocruz), do Centro de Desenvolvimento e Produção de Terapias CAR-T, que vai possibilitar a fabricação nacional de terapias celulares a preços reduzidos... O presidente Luiz Inácio Lula da Silva participou do lançamento, acompanhado do ministro da Saúde, Alexandre Padilha, e do presidente da Fiocruz, Mario Moreira."
At the event, Lula greeted Paulo Peregrino, who was cured of cancer after participating in University of São Paulo (USP) research with similar technology. Peregrino was one of 14 Brazilian patients who underwent CAR-T treatment conducted by USP in partnership with the Butantã Institute. According to him, the treatment cost R$ 2 million at the time. ◦
Press quotes (1)
"A tecnologia CAR-T produzida pela Fiocruz vai beneficiar diretamente pacientes que enfrentam leucemia, linfoma e mieloma. As células de defesa do paciente são removidas, modificadas geneticamente em laboratório e reintroduzidas na pessoa já 'reprogramadas' para combater o câncer... A iniciativa no Brasil faz parte do Programa para Ampliação e Modernização de Infraestrutura do Complexo Econômico-Industrial da Saúde (PDCEIS), vinculado ao Novo PAC (Programa de Aceleração do Crescimento), que já investiu R$ 330 milhões."
The center launch occurred on Saturday (23) with presidential participation, health minister and Fiocruz president
Covered by only some sources, or where the accounts diverge.
Covered by only some sources (1)
CAR-T therapy price target will be 20% of international commercial value (US$ 500,000)
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What formal normative act created the Fiocruz CAR-T production center?
Why it's still unknown: DOU searches did not locate a specific decree, ordinance, or provisional measure establishing the CAR-T Development and Production Center, despite coverage of the presidential launch
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When will ANVISA grant operating authorization for CAR-T therapy production?
Why it's still unknown: ANVISA portal shows no announcement about operating authorization for the Fiocruz center nor regulatory timeline
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What is the clinical trial protocol number on Plataforma Brasil and recruitment start date?
Why it's still unknown: Despite Fiocruz confirming that production will involve clinical trial development, the protocol number on Plataforma Brasil and recruitment timeline were not disclosed