Revolution Medicines Announces FDA Breakthrough Therapy Designation for Elironrasib
Revolution Medicines (NASDAQ:RVMD) announced that the FDA has granted Breakthrough Therapy Designation to its drug elironrasib for treating adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) who have received prior chemotherapy and immunotherapy but haven't been treated with a KRAS G12C inhibitor.
The designation is based on promising results from the Phase 1 RMC-6291-001 clinical trial, which demonstrated competitive antitumor activity, differentiated safety profile, and compelling objective response rate and progression-free survival. Elironrasib targets the RAS(ON) form of RAS G12C variant, present in approximately 12% of NSCLC cases.
This breakthrough designation aims to expedite development and review of the drug, addressing a significant unmet medical need in NSCLC, which accounts for 80%-85% of all lung cancers.
Revolution Medicines (NASDAQ:RVMD) ha annunciato che la FDA ha concesso la Breakthrough Therapy Designation al suo farmaco elironrasib per il trattamento di pazienti adulti con carcinoma polmonare non a piccole cellule (NSCLC) avanzato con mutazione KRAS G12C, che hanno già ricevuto chemioterapia e immunoterapia ma non sono stati trattati con un inibitore KRAS G12C.
Questa designazione si basa sui risultati promettenti del trial clinico di fase 1 RMC-6291-001, che ha mostrato un'attività antitumorale competitiva, un profilo di sicurezza distintivo e un tasso di risposta obiettiva e sopravvivenza libera da progressione significativi. Elironrasib agisce sulla forma RAS(ON) della variante RAS G12C, presente in circa il 12% dei casi di NSCLC.
La designazione breakthrough ha l'obiettivo di accelerare lo sviluppo e la revisione del farmaco, rispondendo a un importante bisogno medico insoddisfatto nel NSCLC, che rappresenta tra l'80% e l'85% di tutti i tumori polmonari.
Revolution Medicines (NASDAQ:RVMD) anunció que la FDA ha otorgado la Designación de Terapia Innovadora (Breakthrough Therapy Designation) a su medicamento elironrasib para el tratamiento de pacientes adultos con cáncer de pulmón no microcítico avanzado (NSCLC) con mutación KRAS G12C que han recibido quimioterapia e inmunoterapia previas pero no han sido tratados con un inhibidor de KRAS G12C.
La designación se basa en resultados prometedores del ensayo clínico de fase 1 RMC-6291-001, que demostró una actividad antitumoral competitiva, un perfil de seguridad diferenciado y una tasa de respuesta objetiva y supervivencia libre de progresión destacadas. Elironrasib actúa sobre la forma RAS(ON) de la variante RAS G12C, presente en aproximadamente el 12% de los casos de NSCLC.
Esta designación innovadora busca acelerar el desarrollo y revisión del medicamento, atendiendo una necesidad médica significativa no cubierta en el NSCLC, que representa entre el 80% y 85% de todos los cánceres de pulmón.
Revolution Medicines (NASDAQ:RVMD)는 FDA가 성인 환자 중 KRAS G12C 돌연변이가 있는 진행성 비소세포폐암(NSCLC) 치료제인 엘리론라시브(elironrasib)에 대해 혁신 치료제 지정(Breakthrough Therapy Designation)을 부여했다고 발표했습니다. 이 환자들은 이전에 화학요법과 면역요법을 받았으나 KRAS G12C 억제제로는 치료받지 않은 상태입니다.
이번 지정은 1상 임상시험 RMC-6291-001의 유망한 결과에 근거한 것으로, 경쟁력 있는 항종양 활성, 차별화된 안전성 프로필, 그리고 객관적 반응률과 무진행 생존율이 입증되었습니다. 엘리론라시브는 약 NSCLC 환자의 12%에서 발견되는 RAS G12C 변이의 활성형 RAS(ON)를 표적으로 합니다.
이번 혁신 치료제 지정은 약물 개발과 검토를 신속히 진행하여 NSCLC에서 중요한 미충족 의료 수요를 해결하는 데 목적이 있으며, NSCLC는 전체 폐암의 80%~85%를 차지합니다.
Revolution Medicines (NASDAQ:RVMD) a annoncé que la FDA a accordé la désignation de thérapie révolutionnaire (Breakthrough Therapy Designation) à son médicament elironrasib pour le traitement des patients adultes atteints d’un cancer du poumon non à petites cellules (NSCLC) avancé avec mutation KRAS G12C, ayant déjà reçu une chimiothérapie et une immunothérapie, mais n’ayant pas été traités avec un inhibiteur KRAS G12C.
Cette désignation repose sur des résultats prometteurs de l’essai clinique de phase 1 RMC-6291-001, qui a démontré une activité antitumorale compétitive, un profil de sécurité différencié, ainsi qu’un taux de réponse objective et une survie sans progression convaincants. Elironrasib cible la forme RAS(ON) de la variante RAS G12C, présente dans environ 12 % des cas de NSCLC.
Cette désignation vise à accélérer le développement et l’examen du médicament, répondant à un besoin médical important non satisfait dans le NSCLC, qui représente entre 80 % et 85 % de tous les cancers du poumon.
Revolution Medicines (NASDAQ:RVMD) gab bekannt, dass die FDA seinem Medikament Elironrasib für die Behandlung erwachsener Patienten mit KRAS G12C-mutiertem fortgeschrittenem nicht-kleinzelligem Lungenkrebs (NSCLC), die zuvor Chemotherapie und Immuntherapie erhalten haben, aber noch nicht mit einem KRAS G12C-Inhibitor behandelt wurden, die Breakthrough Therapy Designation erteilt hat.
Die Zulassung basiert auf vielversprechenden Ergebnissen der Phase-1-Studie RMC-6291-001, die eine wettbewerbsfähige antitumorale Aktivität, ein differenziertes Sicherheitsprofil sowie eine überzeugende objektive Ansprechrate und progressionsfreies Überleben zeigte. Elironrasib zielt auf die RAS(ON)-Form der RAS G12C-Variante ab, die in etwa 12 % der NSCLC-Fälle vorkommt.
Diese Breakthrough-Designation soll die Entwicklung und Prüfung des Medikaments beschleunigen und eine bedeutende ungedeckte medizinische Bedarfsstellung beim NSCLC adressieren, das 80-85 % aller Lungenkrebserkrankungen ausmacht.
- FDA Breakthrough Therapy Designation received for elironrasib in KRAS G12C NSCLC
- Phase 1 trial showed highly competitive antitumor activity with differentiated safety profile
- Addresses large market opportunity with KRAS mutations found in nearly 30% of NSCLC cases
- Currently no FDA-approved RAS-targeted inhibitors for KRAS G12C NSCLC, positioning the company as a potential first-mover
- Drug still in early Phase 1 stage of development
- Will face competition from other companies developing KRAS G12C inhibitors
- Limited to specific subset of lung cancer patients with KRAS G12C mutation
Insights
FDA Breakthrough status for elironrasib significantly accelerates approval pathway, addressing critical unmet need in KRAS G12C lung cancer.
This Breakthrough Therapy Designation for elironrasib represents a significant regulatory milestone for Revolution Medicines. The designation, which is granted to expedite development of treatments addressing serious unmet medical needs, validates the drug's promising clinical profile in KRAS G12C-mutated non-small cell lung cancer (NSCLC) patients who have exhausted standard chemotherapy and immunotherapy options.
What makes this particularly notable is that elironrasib targets the RAS(ON) form of the KRAS G12C mutation - the active, disease-driving state of the protein. This mechanistic approach differentiates it from first-generation KRAS inhibitors. The Phase 1 data must have shown compelling efficacy signals, as the FDA requires preliminary clinical evidence demonstrating substantial improvement over existing therapies to grant this designation.
The addressable market is substantial - NSCLC accounts for 80-85% of lung cancers, with most patients diagnosed at advanced stages. KRAS mutations appear in nearly 30% of NSCLC cases, with G12C being the most common variant. Critically, the press release notes there are currently no FDA-approved RAS-targeted inhibitors for KRAS G12C NSCLC, highlighting the significant unmet need.
This designation provides Revolution Medicines with enhanced FDA interaction, potential eligibility for accelerated approval and priority review, and reinforces the company's emerging leadership in the competitive RAS inhibitor landscape. The mention of a second compound (daraxonrasib) with Breakthrough status for pancreatic cancer further validates their platform approach to targeting RAS-driven cancers.
- Breakthrough Therapy Designation granted to elironrasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor
- Designation based on encouraging clinical data observed with elironrasib in patients with advanced KRAS G12C non-small cell lung cancer
REDWOOD CITY, Calif., July 23, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to elironrasib, the company’s RAS(ON) G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.
The Breakthrough Therapy Designation is based on data from the Phase 1 RMC-6291-001 clinical trial evaluating elironrasib monotherapy in patients with advanced KRAS G12C solid tumors. Results from the trial have demonstrated highly competitive antitumor activity, including differentiated safety and tolerability along with a compelling objective response rate and progression-free survival.
“There continues to be a need for new targeted therapies for patients with RAS-addicted cancers, and this Breakthrough Therapy Designation from the FDA highlights the therapeutic potential of elironrasib, a differentiated inhibitor, for patients with KRAS G12C lung cancer,” said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “Coming shortly after daraxonrasib was granted a designation for patients with advanced RAS mutant pancreatic cancer, this designation for elironrasib further validates our innovative product engine as a source for novel potential treatment approaches for patients with RAS mutant cancers.”
Elironrasib is an innovative inhibitor that binds selectively and covalently to the oncogenic RAS(ON) form of the RAS G12C variant that drives approximately
NSCLC accounts for
Breakthrough Therapy Designation is intended to expedite the development and review of potential new medicines designed to treat serious conditions and address significant unmet medical needs. Pursuant to FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates substantial improvement on a clinically significant endpoint over available medicines.
About Non-Small Cell Lung Cancer
More than 197,000 people are diagnosed with non-small cell lung cancer (NSCLC) in the U.S. each year.4 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies.
About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding progression of clinical studies and findings from these studies, including the safety, tolerability and antitumor activity of the company’s candidates being studied and the durability of these results; the therapeutic potential of elironrasib; the ability of the company’s product engine to generate potential treatment approaches. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ current stage of development, the process of designing and conducting preclinical and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 7, 2025, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
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1 American Cancer Society. What is Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed July 2025.
2 National Cancer Institute. Non-Small Cell Lung Cancer Treatment. Available at: https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq. Accessed July 2025.
3 Reita D, Pabst L., Pencreach E, et al. Direct Targeting KRAS Mutation in Non-Small Cell Lung Cancer: Focus on Resistance. Cancers (Basel). 2022; 14(15):1321. doi: 10.3390/cancers14051321
4 American Cancer Society. Key Statistics for Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed July 2025.
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