Erasca Inc. said the U.S. Food and Drug Administration granted Fast Track designation to ERAS-0015, an oral pan-RAS molecular glue designed to inhibit RAS signaling, for the treatment of metastatic pancreatic adenocarcinoma.
The designation covers patients with solid tumors harboring RAS mutations, including those with second-line or later KRAS G12X pancreatic ductal adenocarcinoma. Erasca, a San Diego-based clinical-stage precision oncology company, plans to initiate three registration-enabling clinical trials targeting pancreatic and lung cancers.
Preliminary Phase 1 data from the AURORAS-1 trial, disclosed in July 2026, showed a 57% global response rate in patients with second-line or later KRAS G12X pancreatic ductal adenocarcinoma treated with ERAS-0015 monotherapy. The recommended expansion dose evaluated was 32 mg once daily. Responses included confirmed and unconfirmed cases from patients who received their first dose at least eight weeks prior to the May 25, 2026 data cutoff.
Jonathan E. Lim, chairman, CEO and co-founder of Erasca, said the Fast Track designation reflects the urgent need for new therapies in metastatic pancreatic cancer. Erasca expects to report additional Phase 1 monotherapy and combination data, including with panitumumab, in the first half of 2027.
The company’s shares were trading at $17.44 on Monday, down 1.08%.
