Project FrontRunner ... Clearly advantaging TheralaseSo TLD-1433 could be offered much faster to a much larger NMIBC audience. Not only limited to BCG-unresponsive. The timing couldn't be better for TLT and that would make us even more attractive to big pharmas. So instead of just limiting TLD-1433 to those that have tried everything and that face cystectomy, this new revamped Accelerated Approval program would for example allow TLD-1433 to be made available to patients with early stage of NMIBC, assuming TLD-1433 would be so good for late-stage NMIBC conditions, like the one we're currently limited to (unresponsive to SOC (BCG)). With this project, the FDA wants to cut the delays for which a promising treatment would need to become a first-line treatment. Today, treatments starts at the worse conditions (when SOC have failed), and have to prove their ways up to first line treatment, through long clinical trials. That's a long process. That's where the FDA wants to shorten delays, for promising treatments like ours. FDA oncology chief aims to open up accelerated approval for earlier cancer treatment under 'Project FrontRunner'
For decades, the FDA has been offering accelerated approvals to open early access to new cancer drugs, but mostly for patients who’ve already tried several other regimens. FDA oncology chief Richard Pazdur, M.D., now plans to disrupt that longstanding practice with a new initiative.
Called “Project FrontRunner,” the new program will come online later this year, Pazdur, director of the FDA’s Oncology Center of Excellence, told Fierce Biotech in an interview. Although details are still in the works, the program’s theme is clear—to advance accelerated approval to earlier cancer treatment.
“We really want people to be looking at accelerated approval not in the most refractory populations,” Pazdur said, “but let’s move these drugs up to an earlier disease setting as their first approval in randomized studies.”