Erasca has been granted Fast Track Designation by the FDA for ERAS‑0015, an oral pan‑RAS molecular glue being developed for metastatic pancreatic adenocarcinoma. The company said the therapy is designed to inhibit RAS signalling and has shown encouraging activity in early studies.
“Receiving FTD is an important milestone for ERAS‑0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E Lim, MD, Erasca’s chairman, CEO and co‑founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us to rapidly advance the clinical development of ERAS‑0015, including working closely with FDA on a planned Phase 3 trial in pancreatic cancer, alongside two additional potentially pivotal trials in lung cancer.”
He added: “We look forward to reporting additional monotherapy and combination data in the first half of 2027.”
FTD is intended to facilitate development and expedite review of therapies for serious conditions with unmet medical needs. Designated programmes may benefit from more frequent FDA interactions and may be eligible for accelerated approval, priority review and rolling review.
In July 2026, Erasca reported preliminary data from the AURORAS‑1 phase 1 trial showing a 57% uORR8wk in patients with second‑line or later KRAS G12X pancreatic ductal adenocarcinoma receiving ERAS‑0015 monotherapy at the recommended dose for expansion of 32 mg once daily. All responding patients remained on treatment at data cutoff, and the therapy continued to demonstrate favourable tolerability.
Additional data from monotherapy expansion and combination cohorts, including the panitumumab combination, are expected in the first half of 2027.
