FDA Grants Fast Track Designation to ERAS-0015 for Pancreatic Adenocarcinoma

The FDA has granted fast track designation to ERAS-0015, an oral pan-RAS molecular glue, for the treatment of patients with metastatic pancreatic adenocarcinoma, according to a news release from the developer, Erasca, Inc.¹

“Receiving [fast track designation] is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” stated Jonathan E. Lim, MD, chairman, chief executive officer, and co-founder of Erasca, in the press release.¹ “Together with the encouraging clinical activity and favorable tolerability observed to date, this [fast track designation] 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 2 additional potentially pivotal trials in lung cancer.”

What data supported the fast track designation?

The designation follows encouraging activity in the phase 1 AURORAS-1 trial (NCT06983743) for ERAS-0015 across multiple tumor types, which were reported by the developer in July 2026.² ERAS-0015 at the recommended dose for expansion, 32 mg once daily, elicited a 57% unconfirmed overall response rate (ORR) at 8 weeks among patients with second-line or later KRAS G12X–mutant pancreatic ductal adenocarcinoma (PDAC). As of the May 25, 2026, data cutoff, all patients with confirmed and unconfirmed responses across all doses remained on treatment. At 32 mg once daily, 6 of 7 patients remained on treatment and at 24 mg once daily, 6 of 8 patients remained on treatment.

Safety data for the monotherapy remained consistent with the company’s earlier disclosures.³ Treatment-related adverse events (TRAEs) were mostly low grade, with no dose-limiting toxicities (DLTs), a low rate of dose interruptions or reductions due to TRAEs, and no discontinuations due to TRAEs. The median relative dose intensity was 100% at both the 24 mg and 32 mg QD dose levels.

Additional data from the monotherapy expansion and combination dose-escalation cohorts, including a panitumumab (Vectibix) combination arm, are expected in the first half of 2027. The company also plans to initiate a phase 3 trial evaluating ERAS-0015 in first-line PDAC in 2027.

What is ERAS-0015 and how does it work?

ERAS-0015 is an investigational, oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. The agent is also designed to help prevent resistance to mutant-selective RAS inhibitors through inhibition of RAS wildtype variants.

What are Erasca’s registration-enabling development plans?

Erasca is planning 3 potentially registration-enabling trials for ERAS-0015 spanning pancreatic and lung cancers. The company intends to initiate a phase 3 trial in first-line PDAC in 2027, a potentially registration-enabling trial in second-line or later non–small cell lung cancer (NSCLC) in the first half of 2027, and an additional phase 3 trial in RAS-mutant NSCLC between the second half of 2027 and the first half of 2028.

The developers are also investigating ERAS-0015 in combination with panitumumab in metastatic colorectal cancer. No DLTs were observed in the initial 16 mg dose-escalation cohort among 4 DLT-evaluable patients, and dose escalation is ongoing in the 24 mg combination cohort.

How does this fit into the broader pancreatic cancer treatment landscape?

ERAS-0015 joins a growing group of RAS-directed agents earning expedited designations in pancreatic cancer this year. Previously, the FDA granted fast track designation for BBO-11818, an investigational pan-KRAS inhibitor, in advanced KRAS-mutant PDAC.⁴ Pancreatic adenocarcinoma continues to carry a high unmet need, with KRAS mutations present in a majority of cases and few targeted options historically available to patients.

References

1. Erasca granted FDA fast track designation for pan-RAS molecular glue ERAS-0015 in patients with metastatic pancreatic adenocarcinoma. News release. Erasca, Inc. August 24, 2026. Accessed August 25, 2026. https://tinyurl.com/3ab4rety
2. Erasca announces updated preliminary phase 1 data and registration-enabling plans for potentially best-in-class pan-RAS molecular glue ERAS-0015 in KRAS-mutant solid tumors. News release. Erasca, Inc. July 13, 2026. Accessed August 25, 2026. https://tinyurl.com/44ckku2h
3. Erasca announces positive preliminary phase 1 dose escalation data for potentially best-in-class pan-RAS molecular glue ERAS-0015 in KRAS-mutant solid tumors. News release. Erasca, Inc. April 27, 2026. Accessed August 25, 2026. https://tinyurl.com/bdz65t7h
4. BBOT granted U.S. FDA fast track designation for BBO-11818 for the treatment of adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma. News release. BridgeBio Oncology Therapeutics. April 20, 2026. Accessed August 25, 2026. https://tinyurl.com/bva5mnc4