The timing of 2 FDA programs could suit TLT Two FDA programs perfectly suited for us. The timing couldn't be better.
This could allow TLT to displace BCG much faster, and in all the stages of NMIBC, not just in the late-stage. And in more countries simultaneously.
Take a look:
A framework for concurrent submission and review of oncology products
March 31, 2022
The FDA Oncology Center of Excellence (OCE) initiated Project Orbis in May 2019 to provide a framework for concurrent submission and review of oncology products among 7 international partners (US, Canada, UK, Australia, Brazil, Switzerland, Israel, Singapore).
2) Project FrontRunner
The Accelerated Approval program is being revamped to bring late-stage drugs faster to early-stage diseases.
April 2022
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.”
May 10, 2022 -