The FDA has granted Fast Track designation to Erasca’s investigational ERAS-0015 for metastatic pancreatic adenocarcinoma following preliminary Phase 1 activity.

FDA Fast Track designation

The US Food and Drug Administration (FDA) has granted Fast Track designation to ERAS-0015, an investigational oral pan-RAS molecular glue being developed by Erasca for patients with metastatic pancreatic adenocarcinoma.

The designation is intended for therapies being developed for serious conditions with unmet medical needs and can provide developers with more frequent interactions with the FDA during development. Eligible programmes can also receive benefits including accelerated approval, priority review and rolling review where the relevant criteria are met.

ERAS-0015 is being evaluated in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumours. The drug is designed to inhibit RAS signalling across RAS variants, with the aim of addressing cancers driven by mutations in the RAS pathway.

The Fast Track designation specifically covers metastatic pancreatic adenocarcinoma.

Preliminary pancreatic cancer activity

The regulatory decision follows updated preliminary Phase 1 data reported by Erasca in July.

At the recommended dose for expansion of 32 mg once daily, ERAS-0015 produced a 57% unconfirmed overall response rate at eight weeks (uORR8wk) among patients with second-line or later KRAS G12X pancreatic ductal adenocarcinoma.

The analysis used a May 25, 2026 data cut-off. The company reported that all responding patients remained on treatment at the time of the analysis and that the drug continued to show a favourable tolerability profile.

The response measure includes both confirmed and unconfirmed responses among patients whose first dose was administered at least eight weeks before the data cut-off. The results therefore represent an early clinical signal rather than evidence of efficacy from a later-stage controlled trial.

Jonathan Lim, chairman, chief executive officer and co-founder of Erasca, said: “Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer.”

He added: “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.”

Development plans

Erasca plans to advance ERAS-0015 into three potentially registration-enabling trials across pancreatic and lung cancers. The company is working with the FDA on a planned Phase 3 study in pancreatic cancer, alongside two additional potentially pivotal studies in lung cancer.

Additional Phase 1 data from monotherapy expansion and combination cohorts are expected in the first half of 2027, including data from a combination programme involving panitumumab.

Earlier AURORAS-1 dose-escalation data showed preliminary responses across several RAS-mutant solid tumours. The programme is designed to assess ERAS-0015 both as a monotherapy and in combination with other treatments.

Fast Track designation does not constitute FDA approval of ERAS-0015 and does not establish the drug’s safety or efficacy. The investigational treatment remains in clinical development, with further studies required to determine whether the early response signals translate into clinically meaningful benefits for patients with pancreatic cancer.