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Re: ATLnsider post# 359859

Monday, 03/08/2021 6:48:56 PM

Monday, March 08, 2021 6:48:56 PM

Post# of 824125
re FDA Real-Time Oncology Review (RTOR) program:
https://www.zs.com/insights/pedal-to-the-metal-assessing-the-fda-s-real-time-oncology-review-program
(Note: I do not see a date for when the above link was posted)
includes:

Currently, the RTOR pilot is only accepting applications for supplemental indications for drugs that have already been approved by the FDA, meaning that new molecular entities (NMEs) are ineligible.


&

So far, there have been four oncology therapeutics (Kisqali, Keytruda, Kyprolis, Adcetris) that have been granted new or extended indications via RTOR, and another four (Tibsovo, Kadcyla, Venclexta, Darzalex) that are currently being reviewed under the RTOR program.


So it appears that DCVax was not under review by RTOR at the time of the article.
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