Benzinga | Apr 27, 2021 07:12AM EDT

Instil Bio Receives FDA Orphan Drug Designation For ITIL-168 in Melanoma

Instil Bio, Inc. ("Instil") (NASDAQ:TIL) received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV with its ITIL-168 TIL therapy.



"The Orphan Drug Designation incentivizes biotech companies to develop new therapies that are important for patients. We are pleased to advance development of ITIL-168 for the treatment of melanoma stages IIB to IV with this designation," said Bronson Crouch, Chief Executive Officer of Instil.

Orphan Drug Designation confers potential benefits to sponsors, including tax credits for qualified clinical testing, waiver of BLA user fees, and eligibility of market exclusivity for 7 years upon marketing approval.