{"id":988369,"date":"2026-08-03T09:06:55","date_gmt":"2026-08-03T13:06:55","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/lillys-olomorasib-receives-u-s-fdas-breakthrough-therapy-designation-for-the-treatment-of-previously-treated-kras-g12c-mutant-advanced-pancreatic-cancer\/"},"modified":"2026-08-03T09:06:55","modified_gmt":"2026-08-03T13:06:55","slug":"lillys-olomorasib-receives-u-s-fdas-breakthrough-therapy-designation-for-the-treatment-of-previously-treated-kras-g12c-mutant-advanced-pancreatic-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lillys-olomorasib-receives-u-s-fdas-breakthrough-therapy-designation-for-the-treatment-of-previously-treated-kras-g12c-mutant-advanced-pancreatic-cancer\/","title":{"rendered":"Lilly’s olomorasib receives U.S. FDA’s Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n INDIANAPOLIS<\/span>, Aug. 3, 2026<\/span> \/PRNewswire\/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA)<\/a>\u00a0has 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<\/i>\u00a0G12C mutation, as determined by an FDA-approved test. Olomorasib is an investigational, potent and highly selective next-generation inhibitor of KRAS G12C.\u00a0Olomorasib was previously granted<\/a>\u00a0Breakthrough 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<\/i>\u00a0G12C mutation and PD-L1 expression \u2265\u00a050%, as determined by FDA approved tests.<\/p>\n

\n Breakthrough Therapy designation<\/a>\u00a0aims 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.<\/p>\n

Pancreatic cancer is diagnosed in approximately 60,000 people in the United States each year, with an estimated 50,000 deaths projected annually.1<\/sup>\u00a0Outcomes for patients with metastatic pancreatic cancer are typically poor, with a five-year survival rate under 5%.2<\/sup>\u00a0Growing evidence suggests outcomes for patients with KRAS<\/i>\u00a0G12C-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<\/sup>\u00a0There currently are no approved therapies that specifically target KRAS <\/i>G12C-mutant pancreatic cancer.<\/p>\n

“Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a KRAS<\/i>\u00a0G12C 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<\/i>\u00a0G12C-driven tumors and reflects our commitment to bringing meaningful new treatment options to patients living with these cancers.”<\/p>\n

The FDA Breakthrough Therapy designation is based on encouraging preliminary results from the open-label, multicenter, Phase 1\/2 LOXO-RAS-20001 study (NCT04956640<\/a>) of olomorasib in patients with KRAS<\/i>\u00a0G12C-mutant, advanced solid tumors, including those with advanced pancreatic cancer who have received at least one prior systemic therapy.<\/p>\n

Lilly is studying olomorasib in KRAS <\/i>G12C-mutant cancers in multiple studies. Details\u00a0on\u00a0the trials can be found by visiting\u00a0clinicaltrials.gov<\/a>.<\/p>\n

\n About LOXO-RAS-20001<\/b>\u00a0\u00a0
LOXO-RAS-20001 is an open-label, multicenter, Phase 1\/2 study evaluating the safety,\u00a0tolerability\u00a0and preliminary efficacy of\u00a0olomorasib\u00a0in patients with\u00a0KRAS<\/i>\u00a0G12C-mutant advanced solid tumors (NCT04956640<\/a>). The study includes a Phase 1a dose escalation\u00a0phase\u00a0of\u00a0olomorasib\u00a0monotherapy in\u00a0KRAS<\/i>\u00a0G12C–<\/i>mutant solid tumors and a Phase 1b dose expansion and optimization\u00a0phase\u00a0which\u00a0are evaluating\u00a0olomorasib\u00a0as a monotherapy and in combination with other treatments.\u00a0<\/p>\n

\n About Olomorasib<\/b>
\n
Olomorasib (LY3537982) is an investigational, oral, potent,\u00a0and highly selective next-generation inhibitor of the KRAS G12C protein. KRAS <\/i>mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, and KRAS<\/i>\u00a0G12C mutations occur in approximately 1% to 2% of patients with pancreatic cancer.4,5<\/sup>\u00a0Olomorasib was specifically designed to target\u00a0KRAS\u00a0G12C and has pharmacokinetic properties which allow for high predicted target occupancy and high potency when used as monotherapy or in combination.6<\/sup><\/p>\n

Olomorasib is currently being studied in the LOXO-RAS-20001 Phase 1\/2 trial (NCT04956640<\/a>) in patients with\u00a0KRAS<\/i>\u00a0G12C-mutant NSCLC and other advanced solid tumors and in the pivotal, registrational SUNRAY-01 global study (NCT06119581<\/a>) investigating olomorasib in combination with pembrolizumab with or without chemotherapy for first-line treatment of\u00a0KRAS<\/i>\u00a0G12C-mutant advanced NSCLC, and the SUNRAY-02 (NCT06890598<\/a>) global study investigating olomorasib in combination with standard of care immunotherapy in patients with resected or unresectable KRAS<\/i>\u00a0G12C-mutant NSCLC. For additional information about olomorasib clinical trials, please refer to\u00a0clinicaltrials.gov<\/a>.<\/p>\n

\n Frequently Asked Questions<\/b>\n <\/p>\n

\n What is Breakthrough Therapy designation and why does it matter?
<\/b>
\n Breakthrough Therapy designation<\/a>\u00a0is granted by the FDA to\u00a0expedite\u00a0the development and review of drugs intended to treat a serious condition when preliminary clinical evidence\u00a0indicate\u00a0the drug may\u00a0demonstrate\u00a0substantial improvement over available therapy on a\u00a0clinically significant endpoint. It\u00a0provides\u00a0more intensive FDA guidance during development and may accelerate the path to approval.<\/p>\n

\n What is<\/b>\u00a0olomorasib?
<\/b>Olomorasib (LY3537982) is an investigational, oral, potent,\u00a0and highly selective next-generation inhibitor of the KRAS G12C protein. Olomorasib was specifically designed to target\u00a0KRAS\u00a0G12C and has pharmacokinetic properties which allow for high predicted target occupancy and high potency when used as monotherapy or in combination.6<\/sup><\/p>\n

\n What is <\/b>
\n
\n KRAS<\/i>
\n <\/b>
\n G12C-mutated advanced pancreatic cancer?<\/b>
\n
\n KRAS <\/i>G12C–<\/i>mutated advanced pancreatic cancer is a rare form of pancreatic cancer that is driven by a specific genetic change called the KRAS<\/i>\u00a0G12C mutation and has spread beyond the pancreas.7<\/sup> KRAS <\/i>mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, and KRAS<\/i>\u00a0G12C mutations occur in approximately 1% to 2% of patients with pancreatic cancer.8,9 <\/sup>\u00a0Pancreatic cancer is a type of cancer that forms in the tissues of the pancreas.10<\/sup>\u00a0Because early-stage pancreatic cancer\u00a0is typically asymptomatic, the vast majority of patients are diagnosed at a locally advanced or metastatic stage where treatment options may be limited.11<\/sup><\/p>\n

\n What data<\/b>\u00a0supported<\/b>\u00a0this Breakthrough Therapy designation?
<\/b>The Breakthrough Therapy designation is based on preliminary results from the Phase 1\/2 LOXO-RAS-20001 study (NCT04956640<\/a>) of olomorasib in patients with KRAS<\/i>\u00a0G12C-mutant, advanced solid tumors, including those with advanced pancreatic cancer who have received at least one prior systemic therapy.<\/p>\n

\n Has<\/b>\u00a0olomorasib<\/b>\u00a0received Breakthrough Therapy designation before?
<\/b>Yes. This is the second Breakthrough Therapy designation for\u00a0olomorasib. The first was granted in September 2025 for olomorasib in combination with anti-PD-1 therapy pembrolizumab\u00a0for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS<\/i>\u00a0G12C mutation and PD-L1 expression \u2265\u00a050%, as determined by FDA approved tests.<\/p>\n

\n What is the current standard of care for advanced pancreatic cancer?<\/b>
\n
The current standard of care for advanced pancreatic cancer consists of systemic chemotherapy, with treatment selection\u00a0guided by a patient’s overall health and performance status. Increasingly, comprehensive genomic profiling at diagnosis is recommended to\u00a0identify\u00a0actionable molecular alterations that may enable targeted therapies.<\/p>\n

\n What is the LOXO-RAS-20001 trial?
<\/b>LOXO-RAS-20001 (NCT04956640<\/a>) is an open-label, multicenter, Phase 1\/2 study evaluating the safety,\u00a0tolerability\u00a0and preliminary efficacy of\u00a0olomorasib\u00a0in patients with\u00a0KRAS<\/i>\u00a0G12C-mutant advanced solid tumors. KRAS <\/i>mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, and KRAS<\/i>\u00a0G12C mutations occur in approximately 1% to 2% of patients with pancreatic cancer.8,9<\/sup>\u00a0The study includes a Phase 1a dose escalation\u00a0phase\u00a0of\u00a0olomorasib\u00a0monotherapy in\u00a0KRAS<\/i>\u00a0G12C–<\/i>mutant solid tumors and Phase 1b dose expansion and optimization\u00a0phases\u00a0which\u00a0are evaluating olomorasib as a monotherapy and in combination with other treatments. More information can be found at clinicaltrials.gov<\/a>.<\/p>\n

\n Where can patients find more information about the LOXO-RAS-20001 trial?
<\/b>Patients and healthcare providers can find more information about the LOXO-RAS-20001 study at clinicaltrials.gov (NCT04956640<\/a>).<\/p>\n

\n About Lilly<\/b>\u00a0
Lilly\u00a0is a medicine company turning science into healing\u00a0to make life better for people around the world.\u00a0We’ve\u00a0been pioneering\u00a0life-changing discoveries for\u00a0150\u00a0years, and today our medicines help\u00a0tens of millions of\u00a0people 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,\u00a0we’re\u00a0motivated 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.\u00a0To learn more, visit\u202fLilly.com<\/a>\u00a0and\u202fLilly.com\/news<\/a>, or follow us on\u00a0Facebook<\/a>,\u00a0Instagram<\/a>, and\u00a0LinkedIn<\/a>.\u00a0P-LLY<\/p>\n

\u00a9 Lilly USA, LLC 2026. ALL RIGHTS RESERVED.<\/p>\n

\n Trademarks and Trade Names
<\/b>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 \u00ae<\/sup> and \u2122 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.<\/p>\n

\n Cautionary Statement Regarding Forward-Looking Statements
<\/b>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\u00a0KRAS<\/i>\u00a0G12C–<\/i>mutant advanced solid tumors\u00a0and 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\u00a0KRAS<\/i>\u00a0G12C–<\/i>mutant advanced solid tumors, that olomorasib receive regulatory approval, or that Lilly will execute its strategy as expected.\u00a0For 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.<\/p>\n

\n Endnotes & References<\/b>\n <\/p>\n

    \n
  1. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024.\u00a0CA Cancer J Clin<\/i>. 2024;74(1):12-49. doi:10.3322\/caac.21820<\/li>\n
  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<\/a><\/li>\n
  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<\/a><\/li>\n
  4. Canon J. et al. Nature 2019, 575, 217-223<\/li>\n
  5. Salem M. et al. Ann Oncol 2021, 32 (3 Suppl): S218<\/li>\n
  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.\u00a0Cancer Research<\/i>. 2021;81(13_Supplement):1259-1259. doi:10.1158\/1538-7445.am2021-1259<\/li>\n
  7. Luo J. KRAS mutation in pancreatic cancer. Semin Oncol. 2021;48(1):10-18. doi:10.1053\/j.seminoncol.2021.02.003<\/li>\n
  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<\/li>\n
  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<\/li>\n
  10. Pancreatic Cancer Treatment (PDQ\u00ae<\/sup>)\u2013Patient Version. National Cancer Institute. Updated July 8, 2026. Accessed July 19, 2026. https:\/\/www.cancer.gov\/types\/pancreatic\/patient\/pancreatic-treatment-pdq<\/a><\/li>\n
  11. S\u00f8reide K, Ismail W, Roals\u00f8 M, Ghotbi J, Zaharia C. Early Diagnosis of Pancreatic Cancer: Clinical Premonitions, Timely Precursor Detection and Increased Curative-Intent Surgery. Cancer Control<\/i>. 2023;30:10732748231154711. doi:10.1177\/10732748231154711<\/li>\n<\/ol>\n
    \n\n\n\n
    \n

    \n
    \n Refer to:<\/b> \u00a0<\/span>\n <\/p>\n<\/td>\n

    		\n

    \n Kyle Owens; owens_kyle@lilly.com<\/a> (Media)<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

    \n \n <\/td>\n\n

    \n Michael Czapar; czapar_michael_c@lilly.com<\/a> (Investors)<\/span>\n <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n

    \n

    \n \"Eli\n <\/p>\n<\/p><\/div>\n

    <\/div>\n

    \n \"Cision\" View original content to download multimedia:https:\/\/www.prnewswire.com\/news-releases\/lillys-olomorasib-receives-us-fdas-breakthrough-therapy-designation-for-the-treatment-of-previously-treated-kras-g12c-mutant-advanced-pancreatic-cancer-302840337.html<\/a><\/p>\n

    SOURCE Eli Lilly and Company<\/p>\n<\/p><\/div>\n

    \"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

    PR Newswire INDIANAPOLIS, Aug. 3, 2026 \/PRNewswire\/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA)\u00a0has 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\u00a0G12C mutation, as determined by an FDA-approved test. Olomorasib is an investigational, potent and highly selective next-generation inhibitor of KRAS G12C.\u00a0Olomorasib was previously granted\u00a0Breakthrough 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\u00a0G12C mutation and PD-L1 expression \u2265\u00a050%, as determined by FDA approved tests. Breakthrough Therapy … <\/p>\n

    Continue reading “Lilly’s olomorasib receives U.S. FDA’s Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-988369","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nLilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/lillys-olomorasib-receives-u-s-fdas-breakthrough-therapy-designation-for-the-treatment-of-previously-treated-kras-g12c-mutant-advanced-pancreatic-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire INDIANAPOLIS, Aug. 3, 2026 \/PRNewswire\/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA)\u00a0has 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\u00a0G12C mutation, as determined by an FDA-approved test. Olomorasib is an investigational, potent and highly selective next-generation inhibitor of KRAS G12C.\u00a0Olomorasib was previously granted\u00a0Breakthrough 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\u00a0G12C mutation and PD-L1 expression \u2265\u00a050%, as determined by FDA approved tests. 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