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Posted On: 07/22/2022 6:59:37 PM
Post# of 148893
Super-speedy cancer drug reviews: FDA unveils new draft guidance to help sponsors apply
How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.
For the last five years, FDA’s Oncology Center of Excellence under Rick Pazdur has been quietly tapped into RTOR to allow sponsors to provide even earlier, segmented submissions of critical efficacy and safety data, thereby enabling these faster evaluations of applications.
On Friday, OCE provided its first draft guidance on the RTOR program, explaining how sponsors can apply, what to submit if accepted, and how RTOR is different from rolling reviews, in that rolling reviews require complete sections (e.g., the complete clinical module) to be submitted prior to a complete application submission.
“At the time top-line results of a pivotal trial(s) are available and the database has been locked, an applicant may apply for review under RTOR by submitting a request via email,” the agency explains. “The applicant should include their top-line results and a written justification explaining how their application demonstrates that it is appropriate.”
Generally, about 20 business days later, the FDA review division will decide if an application can be accepted.
While many of the drugs that have gone through RTOR so far have shaved significant time off their PDUFA dates, the FDA also makes clear in Friday’s draft, that “this may not be feasible for all applications due to specific issues that may be identified with the application or overall workload considerations.”
https://endpts.com/super-speedy-cancer-drug-r...ors-apply/
How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.
For the last five years, FDA’s Oncology Center of Excellence under Rick Pazdur has been quietly tapped into RTOR to allow sponsors to provide even earlier, segmented submissions of critical efficacy and safety data, thereby enabling these faster evaluations of applications.
On Friday, OCE provided its first draft guidance on the RTOR program, explaining how sponsors can apply, what to submit if accepted, and how RTOR is different from rolling reviews, in that rolling reviews require complete sections (e.g., the complete clinical module) to be submitted prior to a complete application submission.
“At the time top-line results of a pivotal trial(s) are available and the database has been locked, an applicant may apply for review under RTOR by submitting a request via email,” the agency explains. “The applicant should include their top-line results and a written justification explaining how their application demonstrates that it is appropriate.”
Generally, about 20 business days later, the FDA review division will decide if an application can be accepted.
While many of the drugs that have gone through RTOR so far have shaved significant time off their PDUFA dates, the FDA also makes clear in Friday’s draft, that “this may not be feasible for all applications due to specific issues that may be identified with the application or overall workload considerations.”
https://endpts.com/super-speedy-cancer-drug-r...ors-apply/
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