Brazil’s health officials have okayed a first-of-its-kind CAR-T Cell therapy trial. Anvisa, the health agency, announced the decision.
Conducted by FUNDHERP and the Butantan Institute, the study will involve 81 patients.
The trial is in its starting phase. It aims to evaluate the treatment’s safety and effectiveness.
Specifically, it targets patients with certain types of recurring blood cancers. Anvisa took 104 days to review the proposal.
In response, FUNDHERP met regulatory needs in 144 days.
This approval marks a joint effort between Anvisa and Brazilian scientists. The goal is to advance therapy options in the public health system.
After giving the nod, Anvisa set a review plan. Regular checks will occur until December 2024 to track progress closely.
If results are positive, quick public access is the aim. Currently, this treatment is only available in private healthcare.
Each patient treatment costs at least 400,000 dollars.
According to Anvisa, three similar products have been registered since 2020. These products treat various blood cancers and rare diseases.
However, they are only available privately. At present, about 40 similar trials have Anvisa’s approval.
Among them, a Phase 1 trial is also taking place in São Paulo’s Albert Einstein Hospital.
Background
This move by Brazil represents a pivotal step in cancer treatment in Latin America. CAR-T therapies have mostly been a high-cost, private-sector service until now.
The public health system’s involvement could democratize access. It’s worth noting that this therapy has seen successful applications elsewhere.
For instance, the U.S. FDA has already approved some CAR-T therapies.
However, this is not a quick fix. While CAR-T shows promise, it’s still a complex and costly procedure.
This trial could be Brazil’s chance to prove its capability in advanced healthcare, paving the way for more innovative solutions in the future.