San Diego-based Erasca, Inc. (Nasdaq: ERAS) announced that the US FDA has granted Fast Track Designation (FTD) to ERAS-0015, an oral pan-RAS molecular glue, for the treatment of metastatic pancreatic adenocarcinoma. The designation, granted August 24, 2026, is the first formal regulatory milestone for the compound anywhere in the world.
ERAS-0015 is a molecular glue designed to inhibit signaling across mutant and wild-type RAS proteins by inducing formation of an inhibitory RAS complex, giving it potential activity across multiple RAS-driven tumor genotypes.
The FTD follows updated Phase I data from AURORAS-1 reported in July, when ERAS-0015 produced a 57% unconfirmed eight-week ORR among seven evaluable patients with second-line or later KRAS G12X pancreatic ductal adenocarcinoma at the 32 mg recommended dose for expansion. Six of the seven remained on treatment at the May 25 cutoff, with no dose-limiting toxicities reported.
The FTD enables more frequent interactions with the FDA and, if applicable criteria are met, potential eligibility for rolling review, accelerated approval, and priority review. Erasca said it plans to use the designation to advance discussions with the agency on a Phase III trial in pancreatic cancer, alongside two additional registration-enabling trials in lung cancer.