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The Real Time Oncology Review Program is a

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sentiment_stocks Member Level  Friday, 06/07/19 04:16:41 PM
Re: exwannabe post# 232148
Post # of 237097 
The Real Time Oncology Review Program is a pilot one; however the program has moved from accepting just supplemental applications to full applications, when they approved a non-supplemental NDA for Novatis' Piqray (alpelisib) on May 24, 2019.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-pi3k-inhibitor-breast-cancer

Quote:
Piqray is the first new drug application (NDA) for a new molecular entity approved under the Real-Time Oncology Review (RTOR) pilot program, which permits the FDA to begin analyzing key efficacy and safety datasets prior to the official submission of an application, allowing the review team to begin their review and communicate with the applicant earlier.



One should also note that this move to non supplemental approvals was never publicly announced.
https://www.raps.org/news-and-articles/news-articles/2019/5/fda-approves-first-nda-under-real-time-oncology-re

Quote:
Up until last Friday, FDA had only approved supplemental new drug applications (sNDAs) and supplemental biologics license applications (sBLAS) under the RTOR pilot. FDA had never even publicly said that it was expanding the RTOR pilot to NDAs until announcing that Piqray’s NDA had been approved.



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