Posted by Michael Wonder on 04 Apr 2018
U.S. FDA grants fast track designation to Taris for TAR-200 (GemRIS) in muscle invasive bladder cancer
3 April 2018 - Designation for patients unfit for curative intent therapy.
Taris today announced that the United States FDA has granted Fast Track designation for TAR-200 (GemRIS) for the treatment of patients with organ-confined or locally-advanced muscle invasive bladder cancer (MIBC) who are unfit for curative intent therapy.
This designation offers TARIS earlier and more frequent opportunities to collaborate with the FDA to expedite development of TAR-200, bringing this treatment more quickly to the patients who need it. This status also provides an opportunity for priority review and submission of completed sections of a new drug application on a rolling basis prior to completion of the full application.
