Roy de Souza, Co-Founder and CEO at BreakBio Corp, shared a post on LinkedIn:
“When I founded BreakBio Corp 7 years ago, most people thought I was naive. Few believed the FDA would be supportive of drugs designed and manufactured per person. But …
The current FDA has decided to be proactive and take the lead:
- The FDA leadership has explicitly said they want cancer cures. This is unprecedented.
- It has created new programs and guidance to help and speed up drug reviews and approvals and encourage US companies like BreakBio to do trials in the US.
And it isn’t just talk.
Over the past year, the FDA launched two major initiatives (CNPV and Operation Trailblazer) that can dramatically speed up drug development and therefore improve cancer treatment for many.
The FDA Is Opening The Door To Personalized Cancer Drugs
In the past, it was the job of biotech companies to create strategies and drugs to cure people and the FDA’s job to regulate.
But the current FDA has decided to be proactive and take the lead. And the FDA leadership has explicitly said they want cancer cures. This is unprecedented.
And it isn’t just talk.
It started with Marty Makary. As FDA Commissioner, he was quite vocal about scanning the drug pipeline for cancer cures, and pushed hard to cut approval times.
Over the past year, the FDA launched two major initiatives:
1. The FDA Commissioner’s National Priority Voucher
Drug companies can apply for the Commissioner’s National Priority Voucher (CNPV) to reduce review times from 6+ months down to 1-2.
Basically, if the FDA thinks your drug is a national health priority, they’ll give you a ‘golden ticket’ to make everything go faster. Regeneron was among the first nine companies to receive it since it was launched in the summer of 2025.
2. Operation Trial Blazer: Keeping Early-Stage Biotech in the U.S.
Launched in June 2026, Operation Trial Blazer is the FDA’s new strategy to radically speed up early-stage clinical trials and stop American biotech companies from moving their research overseas.
Historically, the first phase of human testing has been a slow, bureaucratic bottleneck, tempting many U.S. startups to run their early trials in faster foreign markets. Operation Trial Blazer aims to slash those Phase 1 timelines by 6 to 12 months. By introducing highly flexible ‘master protocols’ and allowing companies to use advanced computer modeling for dose selection, the FDA is turning what used to be a multi-year waiting game into an ultra-fast, collaborative process.
Ultimately, the goal is to make the United States the absolute fastest – and safest – place in the world for a biotech startup to test its first human doses, keeping cutting-edge clinical research firmly rooted at home.”
Other articles about FDA approvals on OncoDaily.