This section highlights FDA-related milestones and regulatory updates for drugs developed by Revolution Medicines (RVMD).
Over the past two years, Revolution Medicines has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
daraxonrasib, RASolve, RMC-6236, and RMC-9805. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
daraxonrasib - FDA Regulatory Timeline and Events
daraxonrasib is a drug developed by Revolution Medicines for the following indication: For previously treated metastatic PDAC in patients with KRAS G12 mutations.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- daraxonrasib
- Announced Date:
- June 23, 2025
- Indication:
- For previously treated metastatic PDAC in patients with KRAS G12 mutations.
Announcement
Revolution Medicines, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to daraxonrasib, the company's RAS(ON) multi-selective inhibitor, for previously treated metastatic PDAC in patients with KRAS G12 mutations.
AI Summary
Revolution Medicines, Inc. announced that the U.S. FDA has granted Breakthrough Therapy Designation to daraxonrasib, its RAS(ON) multi-selective inhibitor, for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring KRAS G12 mutations. This status was awarded based on promising early clinical evidence from a Phase 1 study, suggesting that the drug may improve outcomes in a patient group with limited treatment options. Daraxonrasib works by inhibiting RAS signaling, a key process in cancer growth, and could offer a new targeted approach where current therapies fall short. The Breakthrough Therapy Designation is intended to speed up the development and review process, potentially bringing this innovative treatment to patients faster. Revolution Medicines is also enrolling participants in the global Phase 3 RASolute 302 trial, with initial results expected to further support daraxonrasib’s promising potential in 2026.
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RASolve 301 - FDA Regulatory Timeline and Events
RASolve 301 is a drug developed by Revolution Medicines for the following indication: Treated Patients with RAS Mutant Non-Small Cell Lung Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RASolve 301
- Announced Date:
- May 14, 2025
- Indication:
- Treated Patients with RAS Mutant Non-Small Cell Lung Cancer
Announcement
Revolution Medicines announced the first patient has been dosed in RASolve 301, a global, randomized, open-label Phase 3 clinical trial. RASolve 301 will evaluate the safety and efficacy of daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor, in patients with previously treated, locally advanced or metastatic RAS mutant non-small cell lung cancer (NSCLC) compared to docetaxel chemotherapy.
AI Summary
Revolution Medicines announced that the first patient has been dosed in the global, randomized, open-label Phase 3 RASolve 301 trial. This study will test the safety and effectiveness of daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor, in patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC) that carries RAS mutations. The trial will compare daraxonrasib to standard treatment with docetaxel chemotherapy in patients who have received one to two prior lines of treatment, including platinum-based chemotherapy and an anti-PD-1/PD(L)-1 agent. With approximately 420 patients expected to enroll worldwide, the trial will focus on key outcomes such as progression-free and overall survival in patients with common RAS mutations, aiming to deliver a promising new therapy for those with limited treatment options.
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RMC-6236 - FDA Regulatory Timeline and Events
RMC-6236 is a drug developed by Revolution Medicines for the following indication: Advanced Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RMC-6236
- Announced Date:
- July 8, 2024
- Estimated Event Date Range:
- July 15, 2024 - July 15, 2024
- Target Action Date:
- July 15, 2024
- Indication:
- Advanced Solid tumors
Announcement
Revolution Medicines, announced that it will host an investor webcast to provide an update on its RMC-6236 pancreatic ductal adenocarcinoma (PDAC) clinical development program. Speakers will include members of Revolution Medicines' management team, along with Brian M. Wolpin, M.D., M.P.H., professor of medicine at Harvard Medical School, and director of the Gastrointestinal Cancer Center and Robert T. & Judith B. Hale Chair in Pancreatic Cancer at Dana-Farber Cancer Institute.
AI Summary
Revolution Medicines, a clinical-stage oncology company, announced that it will host an investor webcast to update on its RMC-6236 pancreatic ductal adenocarcinoma (PDAC) clinical development program. The webcast is scheduled for Monday, July 15, 2024 at 8:00 a.m. Eastern Time. During the webcast, company management will share details about the progress of their PDAC program. In addition, Brian M. Wolpin, M.D., M.P.H.—a professor of medicine at Harvard Medical School and the director of the Gastrointestinal Cancer Center at Dana-Farber Cancer Institute—will be a featured speaker. This event provides investors with insights into the clinical efforts and future potential of RMC-6236 as part of Revolution Medicines’ overall strategy to combat RAS-addicted cancers. A live broadcast will be available on the company’s website, and a replay will be offered for at least 14 days.
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RMC-9805 - FDA Regulatory Timeline and Events
RMC-9805 is a drug developed by Revolution Medicines for the following indication: An Oral, Covalent, Mutant-Selective KRASG12D(ON) Inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RMC-9805
- Announced Date:
- April 27, 2025
- Indication:
- An Oral, Covalent, Mutant-Selective KRASG12D(ON) Inhibitor
Announcement
Revolution Medicines, Inc announced new clinical data for zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, as monotherapy in patients with KRAS G12D mutant non-small cell lung cancer (NSCLC).
AI Summary
Revolution Medicines, Inc. has shared new clinical data for its drug zoldonrasib (RMC-9805), a targeted treatment developed specifically for patients with KRAS G12D mutant non-small cell lung cancer (NSCLC). The study looked at zoldonrasib as a standalone treatment and showed promising results. In a Phase 1 trial evaluating advanced solid tumors, patients treated with a 1200 mg daily dose experienced a good safety profile and the drug was well tolerated. The most common side effects were mild to moderate, including nausea, diarrhea, vomiting, and rash. Encouragingly, among the NSCLC patients evaluated, a 61% objective response rate was observed, with 89% achieving disease control. These findings indicate that zoldonrasib may offer a new treatment option for this challenging type of lung cancer, addressing a significant unmet need in patients with KRAS G12D mutant tumors.
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