Lilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer

Rhea-AI Summary

Eli Lilly (NYSE: LLY) announced that the U.S. FDA has granted Breakthrough Therapy designation to investigational KRAS G12C inhibitor olomorasib as monotherapy for adults with previously treated KRAS G12C‑mutant advanced pancreatic cancer, identified by an FDA‑approved test. This designation is based on preliminary data from the ongoing open‑label, multicenter Phase 1/2 LOXO‑RAS‑20001 trial in KRAS G12C‑mutant solid tumors, including pancreatic cancer after at least one prior systemic therapy.

According to Lilly, this is the second FDA Breakthrough Therapy designation for olomorasib, which previously received the status in combination with pembrolizumab (KEYTRUDA) for first‑line KRAS G12C‑mutant NSCLC with PD‑L1 ≥50%. Olomorasib is described as an oral, potent and highly selective next‑generation KRAS G12C inhibitor being studied across multiple global trials.

Positive

• Second FDA Breakthrough Therapy designation for olomorasib across two cancer indications
• Regulatory recognition for KRAS G12C‑mutant advanced pancreatic cancer based on Phase 1/2 LOXO‑RAS‑20001 data
• Expedited FDA development and review pathway may accelerate potential approval timelines for olomorasib
• Pipeline diversification with olomorasib studied in multiple global NSCLC and solid tumor trials

Negative

• None.

News Explained

The FDA designation changes Lilly’s development and review status—not olomorasib’s approval status: it provides more intensive guidance and may accelerate review, while the pancreatic-cancer evidence remains preliminary Phase 1/2 data.

Market Context

Lilly's recent insider record showed Net Selling, while the selected news history included four alig...

Analysis

Lilly's recent insider record showed Net Selling, while the selected news history included four aligned reactions and one divergence. That context supports monitoring subsequent clinical evidence and regulatory progression rather than treating designation as approval.

Key Figures

Breakthrough Therapy designations: 2 designations Prior systemic therapy: at least 1 prior systemic therapy Trial phase: Phase 1/2 +5 more

8 metrics

Breakthrough Therapy designations 2 designations Olomorasib across pancreatic and lung cancers

Prior systemic therapy at least 1 prior systemic therapy Previously treated advanced pancreatic cancer

Trial phase Phase 1/2 LOXO-RAS-20001 study

Annual U.S. pancreatic cancer diagnoses approximately 60,000 people United States each year

Projected annual deaths estimated 50,000 deaths United States annually

Five-year survival rate under 5% Metastatic pancreatic cancer

KRAS G12C mutation frequency approximately 1% to 2% Patients with pancreatic cancer

KRAS mutations in RAS-associated cancers approximately 85% Human RAS-associated cancers

Historical Context

5 past events · Latest: Jul 23 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 23	Phase 3 trial results	Positive	+2.0%	Positive topline obesity-trial results supported a 1.97% 24-hour price reaction.
Jul 22	Earnings scheduling notice	Neutral	-1.1%	Lilly scheduled second-quarter 2026 results and an investor conference call.
Jul 16	Acquisition agreement	Positive	+1.1%	Lilly agreed to acquire AtaiBeckley for cash and milestone-linked consideration.
Jul 09	Research presentation	Neutral	+0.1%	Lilly announced 16 Alzheimer's research abstracts for AAIC 2026.
Jul 09	Research presentation correction	Neutral	+0.1%	A correction reaffirmed Lilly's 16-abstract Alzheimer's research presentation program.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Four of the five selected recent news events had reactions aligned with their positive or neutral news direction, while one diverged.

Key Terms

breakthrough therapy designation, kras g12c, monotherapy, pharmacokinetic properties

4 terms

breakthrough therapy designation regulatory

"the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

kras g12c medical

"patients with advanced pancreatic cancer who have received at least one prior systemic therapy"

A specific mutation in the KRAS gene where the 12th amino acid is changed to cysteine (called G12C), causing cells to grow and divide abnormally — like a car’s gas pedal stuck partly down. It matters to investors because this precise, identifiable change is a target for drugs and diagnostic tests; successful therapies or tests can change treatment standards, create new revenue streams, and alter the outlook for companies in oncology and diagnostics.

monotherapy medical

"to olomorasib as a monotherapy for the treatment of adult patients"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

pharmacokinetic properties technical

"has pharmacokinetic properties which allow for high predicted target occupancy"

Pharmacokinetic properties describe how a drug moves through and is processed by the body — including how it is absorbed, where it travels, how it is broken down, and how it is eliminated. These properties matter to investors because they affect dosing, safety, duration of effect, manufacturing complexity, regulatory review, and the likely market use of a medicine, similar to how a car’s fuel efficiency and range affect its appeal and running costs.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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INDIANAPOLIS, Aug. 3, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib as a monotherapy for the treatment of adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test. Olomorasib is an investigational, potent and highly selective next-generation inhibitor of KRAS G12C. Olomorasib was previously granted Breakthrough Therapy designation, in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%, as determined by FDA approved tests.

Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicate that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.

Pancreatic cancer is diagnosed in approximately 60,000 people in the United States each year, with an estimated 50,000 deaths projected annually.¹ Outcomes for patients with metastatic pancreatic cancer are typically poor, with a five-year survival rate under 5%.² Growing evidence suggests outcomes for patients with KRAS G12C-mutant pancreatic cancer are worse than those without the mutation, underscoring a persistent gap in treatment and an opportunity to address a significant unmet need.³ There currently are no approved therapies that specifically target KRAS G12C-mutant pancreatic cancer.

"Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a KRAS G12C mutation face limited options once their disease progresses," said Jacob Van Naarden, executive vice president, and president of Lilly Oncology. "This Breakthrough Therapy designation reflects the early potential we're seeing with olomorasib in this setting and the critical need for new treatment options. With now two Breakthrough Therapy designations across pancreatic and lung cancers, olomorasib continues to demonstrate broad potential clinical evidence across KRAS G12C-driven tumors and reflects our commitment to bringing meaningful new treatment options to patients living with these cancers."

The FDA Breakthrough Therapy designation is based on encouraging preliminary results from the open-label, multicenter, Phase 1/2 LOXO-RAS-20001 study (NCT04956640) of olomorasib in patients with KRAS G12C-mutant, advanced solid tumors, including those with advanced pancreatic cancer who have received at least one prior systemic therapy.

Lilly is studying olomorasib in KRAS G12C-mutant cancers in multiple studies. Details on the trials can be found by visiting clinicaltrials.gov.

About LOXO-RAS-20001  
LOXO-RAS-20001 is an open-label, multicenter, Phase 1/2 study evaluating the safety, tolerability and preliminary efficacy of olomorasib in patients with KRAS G12C-mutant advanced solid tumors (NCT04956640). The study includes a Phase 1a dose escalation phase of olomorasib monotherapy in KRAS G12C-mutant solid tumors and a Phase 1b dose expansion and optimization phase which are evaluating olomorasib as a monotherapy and in combination with other treatments. 

About Olomorasib
Olomorasib (LY3537982) is an investigational, oral, potent, and highly selective next-generation inhibitor of the KRAS G12C protein. KRAS mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, and KRAS G12C mutations occur in approximately 1% to 2% of patients with pancreatic cancer.^4,5 Olomorasib was specifically designed to target KRAS G12C and has pharmacokinetic properties which allow for high predicted target occupancy and high potency when used as monotherapy or in combination.⁶

Olomorasib is currently being studied in the LOXO-RAS-20001 Phase 1/2 trial (NCT04956640) in patients with KRAS G12C-mutant NSCLC and other advanced solid tumors and in the pivotal, registrational SUNRAY-01 global study (NCT06119581) investigating olomorasib in combination with pembrolizumab with or without chemotherapy for first-line treatment of KRAS G12C-mutant advanced NSCLC, and the SUNRAY-02 (NCT06890598) global study investigating olomorasib in combination with standard of care immunotherapy in patients with resected or unresectable KRAS G12C-mutant NSCLC. For additional information about olomorasib clinical trials, please refer to clinicaltrials.gov.

Frequently Asked Questions

What is Breakthrough Therapy designation and why does it matter?
Breakthrough Therapy designation is granted by the FDA to expedite the development and review of drugs intended to treat a serious condition when preliminary clinical evidence indicate the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. It provides more intensive FDA guidance during development and may accelerate the path to approval.

What is olomorasib?
Olomorasib (LY3537982) is an investigational, oral, potent, and highly selective next-generation inhibitor of the KRAS G12C protein. Olomorasib was specifically designed to target KRAS G12C and has pharmacokinetic properties which allow for high predicted target occupancy and high potency when used as monotherapy or in combination.⁶

What is KRAS G12C-mutated advanced pancreatic cancer?
KRAS G12C-mutated advanced pancreatic cancer is a rare form of pancreatic cancer that is driven by a specific genetic change called the KRAS G12C mutation and has spread beyond the pancreas.⁷ KRAS mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, and KRAS G12C mutations occur in approximately 1% to 2% of patients with pancreatic cancer.^8,9  Pancreatic cancer is a type of cancer that forms in the tissues of the pancreas.¹⁰ Because early-stage pancreatic cancer is typically asymptomatic, the vast majority of patients are diagnosed at a locally advanced or metastatic stage where treatment options may be limited.¹¹

What data supported this Breakthrough Therapy designation?
The Breakthrough Therapy designation is based on preliminary results from the Phase 1/2 LOXO-RAS-20001 study (NCT04956640) of olomorasib in patients with KRAS G12C-mutant, advanced solid tumors, including those with advanced pancreatic cancer who have received at least one prior systemic therapy.

Has olomorasib received Breakthrough Therapy designation before?
Yes. This is the second Breakthrough Therapy designation for olomorasib. The first was granted in September 2025 for olomorasib in combination with anti-PD-1 therapy pembrolizumab for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%, as determined by FDA approved tests.

What is the current standard of care for advanced pancreatic cancer?
The current standard of care for advanced pancreatic cancer consists of systemic chemotherapy, with treatment selection guided by a patient's overall health and performance status. Increasingly, comprehensive genomic profiling at diagnosis is recommended to identify actionable molecular alterations that may enable targeted therapies.

What is the LOXO-RAS-20001 trial?
LOXO-RAS-20001 (NCT04956640) is an open-label, multicenter, Phase 1/2 study evaluating the safety, tolerability and preliminary efficacy of olomorasib in patients with KRAS G12C-mutant advanced solid tumors. KRAS mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, and KRAS G12C mutations occur in approximately 1% to 2% of patients with pancreatic cancer.^8,9 The study includes a Phase 1a dose escalation phase of olomorasib monotherapy in KRAS G12C-mutant solid tumors and Phase 1b dose expansion and optimization phases which are evaluating olomorasib as a monotherapy and in combination with other treatments. More information can be found at clinicaltrials.gov.

Where can patients find more information about the LOXO-RAS-20001 trial?
Patients and healthcare providers can find more information about the LOXO-RAS-20001 study at clinicaltrials.gov (NCT04956640).

About Lilly 
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

© Lilly USA, LLC 2026. ALL RIGHTS RESERVED.

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ^® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about olomorasib as a potential treatment for people with certain KRAS G12C-mutant advanced solid tumors and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that olomorasib will prove to be a safe and effective treatment for people with certain KRAS G12C-mutant advanced solid tumors, that olomorasib receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Endnotes & References

1. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820
2. [SEER] Surveillance, Epidemiology, and End Results (SEER). Cancer stat facts: pancreatic cancer. Published 2025. Accessed May 29, 2026. https://seer.cancer.gov/statfacts/html/pancreas.html
3. Norton C, Shaw MS, Rubnitz Z, et al. KRAS mutation status and treatment outcomes in patients with metastatic pancreatic adenocarcinoma. JAMA Netw Open. 2025;8(1):e2453588. https://doi.org/10.1001/jamanetworkopen.2024.53588
4. Canon J. et al. Nature 2019, 575, 217-223
5. Salem M. et al. Ann Oncol 2021, 32 (3 Suppl): S218
6. Peng S-B, Si C, Zhang Y, et al. Abstract 1259: Preclinical characterization of Ly3537982, a novel, highly selective and potent KRAS-G12C inhibitor. Cancer Research. 2021;81(13_Supplement):1259-1259. doi:10.1158/1538-7445.am2021-1259
7. Luo J. KRAS mutation in pancreatic cancer. Semin Oncol. 2021;48(1):10-18. doi:10.1053/j.seminoncol.2021.02.003
8. Zeitouni D, Pylayeva-Gupta Y, Der CJ, Bryant KL. KRAS Mutant Pancreatic Cancer: No Lone Path to an Effective Treatment. Cancers (Basel). 2016;8(4):45. Published 2016 Apr 18. doi:10.3390/cancers8040045
9. Muller M, Tougeron D. KRAS G12C inhibitors: also a new promising new targeted therapy in advanced pancreatic adenocarcinoma?. Transl Cancer Res. 2023;12(12):3227-3232. doi:10.21037/tcr-23-1629
10. Pancreatic Cancer Treatment (PDQ^®)–Patient Version. National Cancer Institute. Updated July 8, 2026. Accessed July 19, 2026. https://www.cancer.gov/types/pancreatic/patient/pancreatic-treatment-pdq
11. Søreide K, Ismail W, Roalsø M, Ghotbi J, Zaharia C. Early Diagnosis of Pancreatic Cancer: Clinical Premonitions, Timely Precursor Detection and Increased Curative-Intent Surgery. Cancer Control. 2023;30:10732748231154711. doi:10.1177/10732748231154711

Refer to:	Kyle Owens; owens_kyle@lilly.com (Media)
	Michael Czapar; czapar_michael_c@lilly.com (Investors)

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SOURCE Eli Lilly and Company

FAQ

What did the FDA grant to Lilly’s olomorasib for pancreatic cancer in August 2026 (LLY)?

The FDA granted Breakthrough Therapy designation to Lilly’s olomorasib as monotherapy for previously treated KRAS G12C‑mutant advanced pancreatic cancer. According to Lilly, this status is based on preliminary Phase 1/2 LOXO‑RAS‑20001 data and is intended to expedite development and regulatory review.

What is olomorasib and how does it work in KRAS G12C‑mutant cancers (LLY)?

Olomorasib is an investigational oral, potent, highly selective next‑generation inhibitor of KRAS G12C. According to Lilly, it was specifically designed for KRAS G12C with pharmacokinetic properties that support high predicted target occupancy and potency, both as monotherapy and in combination regimens for advanced solid tumors.

Why is Breakthrough Therapy designation for olomorasib important for Lilly (LLY) investors?

Breakthrough Therapy designation can speed FDA guidance and review, potentially shortening time to approval if efficacy is confirmed. According to Lilly, this recognition for olomorasib in KRAS G12C‑mutant pancreatic cancer highlights encouraging early clinical evidence and adds regulatory momentum to a key oncology pipeline asset.

Has Lilly’s olomorasib received Breakthrough Therapy designation before this pancreatic cancer news (LLY)?

Yes. According to Lilly, olomorasib first received Breakthrough Therapy designation in September 2025 in combination with pembrolizumab for first‑line KRAS G12C‑mutant, PD‑L1 ≥50% advanced or metastatic NSCLC. The 2026 designation for pancreatic cancer is its second such regulatory recognition.

What clinical trial data supported the new Breakthrough Therapy designation for olomorasib (LLY)?

The designation is supported by preliminary results from the Phase 1/2 LOXO‑RAS‑20001 study. According to Lilly, this open‑label, multicenter trial evaluates safety, tolerability and preliminary efficacy of olomorasib in KRAS G12C‑mutant advanced solid tumors, including previously treated advanced pancreatic cancer.

In which trials is Lilly currently studying olomorasib for KRAS G12C‑mutant cancers (LLY)?

Olomorasib is being studied in the Phase 1/2 LOXO‑RAS‑20001 trial and in global SUNRAY‑01 and SUNRAY‑02 NSCLC studies. According to Lilly, these trials evaluate olomorasib as monotherapy and in combinations with pembrolizumab, chemotherapy or standard immunotherapy in KRAS G12C‑mutant solid tumors.

How common is KRAS G12C‑mutant advanced pancreatic cancer targeted by olomorasib (LLY)?

KRAS mutations are present in about 90% of pancreatic cancers, while KRAS G12C occurs in roughly 1%–2% of pancreatic patients. According to Lilly, this KRAS G12C‑mutant subgroup currently lacks approved targeted therapies and is associated with particularly poor outcomes.