Atualmente, porém, fora da emergência da Covid-19, um novo fármaco convencional leva, no Brasil, aproximadamente 18 meses para ser aprovado após a submissão. É muito tempo. Milhares de pacientes aguardam essas aprovações para poderem se beneficiar dos tratamentos com essas novas moléculas.

A ANVISA caminha nas parcerias com outras agências reguladoras no sentido de haver harmonização nas análises técnicas dos dossiês de registro e busca de soluções compartilhadas, principalmente com o FDA, que na maioria das vezes recebe em primeira mão a documentação de uma nova molécula em câncer.

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A Anvisa publicou a Portaria 1.520-2019, aprovando o modelo de atuação regulatória para a incorporação de temas desenvolvidos pelo Conselho Internacional para Harmonização de Requisitos Técnicos para Produtos Farmacêuticos de Uso Humano (Internationa lCouncil for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – ICH).

De modo geral, o objetivo dessa iniciativa era preparar as unidades da Agência para a sua adequada participação no desenvolvimento e na internalização das recomendações pactuadas pelo ICH para os países-membros. Visava também aprimorar a atuação do Brasil no Conselho, que é o mais importante fórum internacional de convergência regulatória na área de medicamentos. A Anvisa é membro do ICH desde 2016. O conselho reúne autoridades reguladoras e associações de indústrias farmacêuticas de vários países, com o intuito de discutir aspectos técnicos e científicos relacionados ao registro de medicamentos. Isso permite a convergência de regulamentos sem ferir a autonomia do país, garantindo produtos de alta qualidade, segurança e eficácia.

A oncologia é a principal área terapêutica que desenvolve novas tecnologias atualmente e milhares de pacientes necessitam de novas opções de tratamento. Nessa especialidade novas moléculas podem ser a última opção.

Desde 2020, a Anvisa estabeleceu parceria com o Projeto Orbis (Project Orbis). Criado para fornecer uma estrutura para submissão e análise simultâneos de produtos oncológicos entre as agências reguladoras internacionais participantes, o projeto é uma iniciativa do Centro de Excelência em Oncologia (Oncology Center of Excellence – OCE), que integra a agência norte-americana de regulação de alimentos e medicamentos (Food and Drug Administration – FDA). O Brasil iniciou em 2020 uma participação tímida, mas atualmente (2022) sua participação é mais efetiva.

Em 2021, o projeto Orbis cocluiu 26 projetos, sendo que o Brasil participou de 11 (Daratumumab + Hialuronidase, Iorlatinib, Nivolumab, Pembrolizumab (4), Amivantamab, Sorotasib, Ruxolitinib, Abemaciclib e Atezolizumab). No ano anterior, o projeto Orbis concluiu 22 projetos, sendo que o Brasil participou de 3 (Nivolumab + Ipilimumab, Venetoclax e Osimertinib). O relatório oficial do Projeto Orbis de 2022 ainda não foi divulgado.

Os países atualmente participantes do Projeto Orbis são: Estados Unidos, Canadá, Australia, Reino Unido, Suíça, Israel, Brasil e Singapura.

De acordo com as principais conclusões do relatório do Instituto IQVIA “Global OncologyTrends 2022 – Outlook 2026”, as pesquisas clínicas em oncologia começam a atingir níveis historicamente altos em 2021, sendo 56% acima de 2016, e são focadas principalmente nas indicações de câncer raro. Um recorde de 30 novas substâncias ativas oncológicas (NASs) foram inicialmente lançadas globalmente em 2021, sendo que 159 foram lançadas desde 2012.

Oncologistas relatam que o número de casos novos está 20% a 29% abaixo dos níveis pré-COVID-19, enquanto os exames de câncer nos EUA voltaram aos níveis pré-pandêmicos. Mais de 30 milhões de exames em quatro tipos comuns de câncer foram interrompidos durante o período da pandemia, arriscando atrasos ou perdendo diagnósticos em mais de 58 mil pacientes

O número global de pacientes tratados aumentou a uma média de 4% nos últimos cinco anos. Os gastos globais de tratamento em oncologia devem exceder US$ 300 bilhões até 2026.

Assim como a Covid-19 acelerou os processos de aprovação das vacinas, projetos específicos como o Orbis aceleram as aprovações e acesso a medicamentos oncológicos concentrando esforços regulatórios. A pandemia do Covid-19 prejudicou os diagnósticos precoces e, consequentemente, o tratamento nas formas iniciais, que são mais efetivos.

Ideias para agilizar as aprovações de novas moléculas em oncologia são necessárias e a inteligência artificial pode ajudar nesse sentido.

Dr. Helio Osmo
MD, MBA e sócio-fundador da Science & Strategy

The post Convergência regulatória ANVISA-FDA visa acelerar prazos para aprovar novos medicamentos first appeared on NuOn Health.

FDA authorises Omicron boosters for kids as young as 5

The FDA on Wednesday broadened the eligibility of bivalent COVID-19 booster vaccines targeting Omicron by allowing their use in even younger children. Specifically, the agency has cleared the way for Pfizer/BioNTech’s modified vaccine to be given to children as young as five years old at least two months after they completed their primary series or received a prior booster dose, while Moderna’s adapted shot can be given to children as young as six years old following a similar time lapse.

The modified shots contain mRNA components that target the original SARS-CoV-2 strain as well as the BA.4 and BA.5 subvariants. The latest nod extends the emergency-use authorisation (EUA) that had been granted to both bivalent vaccines in late August. At the time, Pfizer/BioNTech’s shot was cleared for people 12 and older, while Moderna’s was permitted for use in adults. Both Omicron-adapted booster vaccines are to be given at smaller doses for the younger population cleared on Wednesday.

Back to pre-pandemic life
“Since children have gone back to school in person and people are resuming pre-pandemic behaviours and activities, there is the potential for increased risk of exposure to the virus,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalised… Vaccination remains the most effective measure to prevent the severe consequences of COVID-19,” he said.

For the updated Pfizer/BioNTech vaccine, the FDA relied in part on its previous analysis of immune response and safety data of adults over 55 who had received a booster dose of the companies’ BA.1-targeting vaccine. The agency also looked at a prior analysis of safety and effectiveness data for Pfizer/BioNTech’s monovalent COVID jab in children ages 5 through 11 years.

Meanwhile, Moderna’s application also included data for an investigational BA.1-targeting vaccine given to people over 18 years old. In addition, the FDA looked at data regarding a single booster dose of Moderna’s monovalent vaccine in children ages 6 years through 17 years, and said the extra shot induced immune responses that were “comparable” to those seen in adults after a two-dose primary series. The data for Moderna’s monovalent vaccine “are relevant to the [bivalent version] because these vaccines are manufactured using the same process,” the agency said.

Pfizer/BioNTech, which have submitted a similar filing to the European Medicines Agency and plan more “in the coming weeks” with other regulatory bodies, said they expect trial results of testing their updated boosters in children in the months ahead. Moderna is also testing its updated booster shot in children.

Meanwhile, US Centers for Disease Control and Prevention (CDC) director Rochelle Walensky signed off on the Omicron-adapted shots just hours after the FDA authorisation, allowing pharmacists to soon start administering the shots. Walensky made the decision without a meeting of the CDC’s independent panel of vaccine experts.

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(Texto original, publicado em inglês)

FDA clears GSK’s Boostrix for use during pregnancy to prevent pertussis in newborns

The FDA on Friday said it is allowing GlaxoSmithKline’s Boostrix (Tdap) vaccine to be given during the third trimester of pregnancy to prevent whooping cough in infants younger than two months old. Boostrix was already indicated for active booster immunisation against tetanus, diphtheria and pertussis in individuals aged 10 years and up, but the agency says the latest nod makes it the first approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated while pregnant.

The decision was based on a re-analysis of Boostrix-relevant data from an observational case-control study of Tdap vaccine effectiveness. Data were derived from 108 cases of pertussis in infants younger than two months old, and 183 control infants who did not have pertussis. The groups included four cases and 18 cases, respectively, whose mothers had received Boostrix during the third trimester.

The FDA said the re-analysis yielded a preliminary estimate of Boostrix being 78% effective at preventing pertussis in these infants. Updated statistical analyses using data from published observational studies also provided estimates of effectiveness that were “consistent” with the preliminary 78% estimate, the agency added.

Meanwhile, it said safety of the vaccine used in this way was assessed in a randomised, placebo-controlled study involving a non-US formulation of Boostrix that contains the same components as the US version, but more aluminum per dose. The study included 680 pregnant women who received either Boostrix or placebo. After childbirth, placebo recipients were then vaccinated with Boostrix. Results showed comparable rates of side effects, whether the vaccine was given during pregnancy or after childbirth. The study did not identify any vaccine-related adverse effects on pregnancy or on the foetus/newborn, the FDA said.

The post FDA libera Boostrix da GSK para uso durante a gravidez para prevenir coqueluche em recém-nascidos first appeared on NuOn Health.

(Texto original, publicado em inglês)

Gilead nabs FDA priority review for Trodelvy in HR+/HER2- breast cancer

Gilead Sciences on Tuesday announced that Trodelvy (sacituzumab govitecan-hziy) has been granted a priority review by the FDA for another breast cancer indication. The designation is for a supplemental filing requesting that the Trop-2-directed antibody be approved for adults with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have progressed on endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Bill Grossman, the company’s therapeutic area head for oncology clinical development, said “Trodelvy has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and today’s news marks our third supplemental application acceptance within the last two years.” A target action date has been set for February 2023.

The latest filing is based on data from the Phase III TROPiCS-02 study, which met its primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS) over physician’s choice of chemotherapy. In findings presented at this year’s American Society of Clinical Oncology (ASCO) meeting, Trodelvy reduced the risk of disease progression or death by 34%, with patients achieving median PFS of 5.5 months, which was 1.5 months longer than the comparator group. The drug was also associated with a 21% decrease in the risk of death, with the two groups surviving a median 14.4 months versus 11.2 months, respectively.

The post Gilead obtém revisão prioritária da FDA para Trodelvy no câncer de mama HR+/HER2- first appeared on NuOn Health.