Posted by Michael Wonder on 01 Apr 2019
OncoSec announces advanced therapy medicinal product classification from the EMA for TAVO in refractory metastatic melanoma
1 April 2019 - Classification as an ATMP Positions TAVO for accelerated review and approval in Europe.
OncoSec Medical announced today that it has received Advanced Therapy Medicinal Product (ATMP) classification for the Company's lead investigational product candidate, TAVO (DNA plasmid vector expressing IL-12 gene), as a potential treatment for refractory metastatic melanoma from the EMA.
In February 2017, the U.S. FDA designated the investigation of OncoSec's TAVO in combination with Keytruda (pembrolizumab) to stop or cause the regression of the tumor of patients with Stage III/IV melanoma who are progressing on either Keytruda (pembrolizumab) or Opdivo (nivolumab) treatment as a fast track development program. Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation is eligible for Accelerated Approval if relevant criteria are met.
