SAN DIEGO, — Erasca, Inc. , a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ERAS-0015 for the treatment of patients with metastatic pancreatic adenocarcinoma. ERAS-0015 is an oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile.

“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, M.D., 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. We look forward to reporting additional monotherapy and combination data in the first half of 2027.”

FTD is intended to facilitate development and expedite the review of therapies for serious conditions with unmet medical needs. Designated programs may benefit from more frequent interactions with the FDA and, if relevant criteria are met, may be eligible for benefits such as accelerated approval, priority review, and rolling review.

In July 2026, Erasca reported updated preliminary data from the AURORAS-1 Phase 1 trial in the U.S. demonstrating encouraging clinical activity, including a 57% uORR_8wk in patients with second-line or later (2L+) KRAS G12X pancreatic ductal adenocarcinoma (PDAC) receiving ERAS-0015 monotherapy at the recommended dose for expansion (RDE) of 32 mg once daily.¹ All responding patients across doses remained on treatment as of the data cutoff, and ERAS-0015 continued to demonstrate favorable tolerability.² Additional data from the monotherapy expansion and combination dose escalation cohorts, including the panitumumab combination, are expected in the first half of 2027.

About ERAS-0015
ERAS-0015 is an investigational, oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. Erasca is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors. Early dose escalation data in AURORAS-1 demonstrated favorable safety and tolerability results, well-behaved, linear PK, and confirmed and unconfirmed partial responses in multiple patients across multiple tumor types with different RAS mutations, including confirmed partial responses at doses as low as 8 mg once daily (QD). ERAS-0015 is also designed to prevent resistance against mutant-selective inhibitors through inhibition of RAS wildtype variants. In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties in multiple animal species.

About Erasca
At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of patients with cancer. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.