Theralase Technologies Inc. V.TLT

FDA Breakthrough Therapy in 2023 …

[ScienceFirst]

So far in 2023:

https://www.fda.gov/media/97001/download

Since inception in 2013:

https://www.fda.gov/media/95302/download

[ScienceFirst]

  If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug.  All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.    Administration Safety and Innovation Act (FDASIA) was signed. FDASIA Section 902 provides for a new designation

[Eoganacht]

It looks like there were 6 BTDs granted in 2023. 2 of them were for the Keytruda - Padcev combo treatment for metastatic urothelial carcinoma. This combo treatment also got accelerated approval on April 3.