Immutep Gets Fast Track Designation for Eftilagimod Alpha Cancer Treatment
04 Octubre 2022 - 7:53AM
Noticias Dow Jones
By Chris Wack
Immutep Ltd. said Tuesday that the U.S. Food and Drug
Administration granted fast track designation to eftilagimod alpha
IMP321 in combination with pembrolizumab for the treatment of first
line non-small cell lung cancer.
Efti is the company's first-in-class soluble LAG-3 clinical
stage candidate which activates antigen presenting cells to engage
both the innate and adaptive immune system to target solid
tumors.
The FDA's fast track designation process is designed to
facilitate the development and expedite the review of drug
candidates to treat serious conditions and fill an unmet medical
need. Immutep will now have access to more frequent interactions
with the FDA to discuss efti's development path and, if relevant
criteria are met, eligibility for rolling review, accelerated
approval, and priority review.
This is the second fast track designation that efti has
received, following receipt of the same designation in April 2021
for efti in combination with pembrolizumab in 1st line treatment of
recurrent or metastatic head and neck squamous cell carcinoma, the
company said.
Immutep shares were up 9% to $1.74 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 04, 2022 08:38 ET (12:38 GMT)
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