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Revolution Medicines Receives FDA Breakthrough Therapy Designation for Lung Cancer Treatment
ByAinvest
Wednesday, Aug 13, 2025 3:21 pm ET1min read
Revolution Medicines has received FDA Breakthrough Therapy Designation for elironrasib (RMC-6291) to treat KRAS G12C-mutated non-small cell lung cancer. The designation aims to expedite development and review of the drug, which addresses a significant unmet medical need. Elironrasib selectively binds to the oncogenic RAS(-ON) form of the RAS G12C variant, a driver in ~12% of NSCLC cases.
Revolution Medicines, Inc. has received FDA Breakthrough Therapy Designation for elironrasib (RMC-6291) to treat KRAS G12C-mutated non-small cell lung cancer (NSCLC). The designation aims to expedite the development and review process of the drug, addressing a significant unmet medical need. Elironrasib selectively binds to the oncogenic RAS(-ON) form of the RAS G12C variant, which is a driver in approximately 12% of NSCLC cases [1].The FDA Breakthrough Therapy Designation recognizes the potential of elironrasib to significantly improve the treatment of KRAS G12C-mutated NSCLC. This designation is granted to drugs that demonstrate substantial improvement over existing therapies or that address a significant unmet medical need. The expedited review process can significantly reduce the time it takes for the drug to reach patients, potentially saving lives and improving patient outcomes [2].
Revolution Medicines has been actively pursuing the development of targeted therapies for various types of cancer. The company's focus on KRAS G12C mutations is part of a broader strategy to address unmet medical needs in oncology. The company has also partnered with Iambic Therapeutics to leverage AI-powered drug discovery tools, further accelerating its drug development pipeline [3].
The Breakthrough Therapy Designation for elironrasib is a significant milestone for Revolution Medicines. It not only recognizes the potential of the drug but also provides the company with access to certain regulatory pathways and incentives that can help expedite the drug's development and approval. This designation also underscores the company's commitment to developing innovative therapies for cancer patients.
References:
[1] https://www.marketscreener.com/news/revolution-medicines-q2-loss-widens-ce7c5ededd8bf327
[2] https://www.genengnews.com/topics/cancer/bayer-kumquat-target-kras-variant-in-up-to-1-3b-cancer-collaboration/
[3] https://www.biopharmadive.com/news/bayer-buys-into-kras-cancer-drug-novartis-immune-therapy-goes-3-for-3/757400/
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