Brazil is solidifying its position as a leading destination for cancer drug clinical trials, attracting significant investment and activity from multinational pharmaceutical companies. The country's growing research and development capabilities, coupled with a supportive regulatory environment, are making it an increasingly attractive location for conducting oncology studies.
Key Players and Clinical Focus
Several major pharmaceutical companies have established a strong presence in Brazil's oncology clinical trial landscape. Roche is a prominent player, conducting trials involving drugs like Atezolizumab for various cancer types and Pertuzumab for breast cancers. Other key companies include Pfizer, Bristol Myers Squibb (BMS), Merck, AstraZeneca, Novartis, Amgen, and Johnson & Johnson, each contributing to the country's clinical trial ecosystem.
Non-small cell lung cancer (NSCLC) is a primary focus in Brazilian clinical trials, reflecting the high incidence of lung cancer in the country. AstraZeneca's Osimertinib, a targeted therapy for NSCLC with EGFR mutations, is being evaluated in multiple clinical trials. Amivantamab, developed by Janssen and Genmab, is under review by Brazil's National Health Surveillance Agency (ANVISA) for NSCLC treatment with EGFR mutations. Clinical trials in Brazil also frequently target breast cancer, lymphoma, melanoma, prostate cancer, colorectal cancer, and renal cancer.
Combination Therapies and Trial Phases
The Brazilian clinical trial landscape emphasizes combination therapies, aligning with the global trend toward multi-modal cancer treatment approaches. Trials are exploring the synergistic effects of combining immunotherapies with targeted therapies or conventional treatments. Agenus' Balstilimab, combined with the anti-CTLA-4 antibody botensilimab, is under investigation for treating colorectal cancer in Brazil. Capecitabine, already approved for breast cancer, is in Phase III trials to assess its efficacy when combined with docetaxel or vinorelbine for breast cancer treatment.
Phase III trials constitute the majority of cancer drug candidates in Brazil, highlighting the country's importance in late-stage clinical development. Over 100 cancer drugs are currently undergoing Phase III clinical trials in Brazil, with potential approvals anticipated in the near future. These trials are essential for establishing the safety and efficacy of new treatments compared to the current standard of care.
CROs and Regulatory Support
Contract Research Organizations (CROs) are integral to Brazil's cancer drug clinical trial landscape, providing essential services such as patient recruitment, trial management, and regulatory support. Major global and local CROs, including Cohortias, SGS, ACTIVA CRO, and CIDP, have a strong presence in Brazil, facilitating complex oncology clinical trials. The Brazilian Association of CROs (ABRACRO) is also enhancing regulatory processes and promoting scientific and educational initiatives within the sector.
Brazil is poised to continue its crucial role in global oncology research, contributing to the development of new cancer treatments that benefit patients both locally and globally.
