Aura Biosciences announced that it has received an agreement from the FDA under a special protocol assesment for the design of a phase 3 trial assessing belzupacap sarotalocan, according to a press release.
Belzupacap sarotalocan (bel-sar) is used to treat early-stage choroidal melanoma.
“This written agreement from the FDA is consistent with our regulatory strategy and reaffirms that the design and planned analysis of the CoMpass phase 3 clinical trial, if successful, adequately address the objectives necessary to support a biologics license application submission for bel-sar for the