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, Zoldonrasib, elironrasib, RASolve, RMC-9805, and RMC-6236. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- April 21, 2026
- Indication:
- For previously treated metastatic PDAC in patients with KRAS G12 mutations.
Announcement
Revolution Medicines, Inc announced that detailed results from the global, randomized Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) will be presented in a Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026 in Chicago.
AI Summary
Revolution Medicines announced that detailed results from the global, randomized Phase 3 RASolute 302 trial of daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) will be presented in a Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 29–June 2, 2026, in Chicago.
The company also had additional Revolution Medicines–sponsored abstracts accepted for online publication. Daraxonrasib is designed to target cancers driven by a broad range of common RAS mutations and is being evaluated in three other global Phase 3 registrational trials, including in PDAC and metastatic RAS-mutant non-small cell lung cancer (NSCLC).
Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors. This matters because PDAC is highly lethal: about 60,000 U.S. diagnoses and 50,000 deaths yearly, over 90% of tumors have RAS mutations, and five-year survival is roughly 3%.
Read Announcement- Drug:
- daraxonrasib
- Announced Date:
- April 13, 2026
- Indication:
- For previously treated metastatic PDAC in patients with KRAS G12 mutations.
Announcement
Revolution Medicines announced positive topline results from its global, randomized, controlled Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who had been previously treated.
Read Announcement- Drug:
- daraxonrasib
- Announced Date:
- April 2, 2026
- Indication:
- For previously treated metastatic PDAC in patients with KRAS G12 mutations.
Announcement
Revolution Medicines announced that it has begun treating patients in RASolute 303, a global Phase 3 clinical trial evaluating daraxonrasib as monotherapy and in combination with chemotherapy in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC), a disease predominantly driven by oncogenic RAS variants.
Read Announcement- Drug:
- daraxonrasib
- Announced Date:
- December 18, 2025
- Indication:
- For previously treated metastatic PDAC in patients with KRAS G12 mutations.
Announcement
Revolution Medicines announced the first patient has been randomized in the RASolute 304 trial.
AI Summary
Revolution Medicines announced the first patient has been randomized in RASolute 304, a global, open-label Phase 3 trial testing daraxonrasib in people with resectable pancreatic ductal adenocarcinoma (PDAC) who have had surgery and perioperative chemotherapy. The study plans to enroll about 500 patients whose tumors carry oncogenic RAS mutations. It will compare daraxonrasib to observation to see if the drug can lengthen disease-free survival after surgery.
The trial’s primary endpoint is disease-free survival; secondary endpoints include overall survival, safety, and tolerability. Company leader Alan Sandler said starting this study lets the team test daraxonrasib earlier in treatment, with the hope of improving long-term disease-free survival for patients with RAS-mutant pancreatic cancer. Daraxonrasib is being studied in multiple global Phase 3 trials, including other PDAC studies and a trial in RAS-mutant non-small cell lung cancer.
Read Announcement- Drug:
- daraxonrasib
- Announced Date:
- October 27, 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 Orphan Drug Designation to daraxonrasib, the company's RAS(ON) multi-selective inhibitor, for the treatment of pancreatic cancer.
AI Summary
Revolution Medicines, Inc. announced the FDA granted Orphan Drug Designation to daraxonrasib, its RAS(ON) multi-selective inhibitor, for treating pancreatic cancer. Pancreatic ductal adenocarcinoma is a lethal form of cancer with few effective therapies. Daraxonrasib targets key RAS mutations found in more than 90% of pancreatic tumors, aiming to block RAS signaling and tumor growth.
The drug is currently being evaluated in a global Phase 3 clinical trial called RASolute 302 for patients with second-line metastatic PDAC. The company also plans to launch two more Phase 3 studies: one for first-line treatment and another as adjuvant therapy after surgery.
Orphan Drug Designation supports development of treatments for rare diseases affecting under 200,000 people in the U.S. It offers tax credits, fee waivers and up to seven years of market exclusivity, spurring continued research on daraxonrasib for this urgent unmet medical need.
Read Announcement- Drug:
- daraxonrasib
- Announced Date:
- September 10, 2025
- Indication:
- For previously treated metastatic PDAC in patients with KRAS G12 mutations.
Announcement
Revolution Medicines, Inc announced key clinical updates from its daraxonrasib Phase 1 clinical trials.
AI Summary
Revolution Medicines announced updates from its Phase 1 trials of daraxonrasib in metastatic pancreatic ductal adenocarcinoma. The results include long-term follow-up in second-line patients and initial monotherapy and chemo-combination data in first-line patients.
In second-line and beyond patients (n=83) on 300 mg daily daraxonrasib, safety remained consistent and no new signals emerged. Among 26 patients with G12X mutations, the confirmed ORR was 35% and DCR 92%, with median PFS of 8.5 months.
For first-line monotherapy (n=40), the 300 mg dose showed a safety profile similar to second-line. In 38 evaluable patients, the ORR was 47% and DCR 89% after a median follow-up of 9.3 months.
In the combination of daraxonrasib 200 mg plus gemcitabine/nab-paclitaxel (n=40), the regimen was well tolerated. Among 31 patients, the ORR reached 55% and DCR 90%. These findings support a three-arm Phase 3 trial in Q4 2025.
Read Announcement- 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.
Read Announcement
Zoldonrasib FDA Regulatory Timeline and Events
Zoldonrasib is a drug developed by Revolution Medicines for the following indication: for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC.
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:
- Zoldonrasib
- Announced Date:
- April 19, 2026
- Indication:
- for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC
Announcement
Revolution Medicines, Incannounced updated Phase 1 (RMC-9805-001) clinical data for zoldonrasib, an oral RAS(ON) G12D-selective inhibitor, in patients with previously treated KRAS G12D non-small cell lung cancer (NSCLC).
AI Summary
Revolution Medicines announced updated Phase 1 (RMC-9805-001) clinical data for zoldonrasib, an oral RAS(ON) G12D-selective inhibitor, in patients with previously treated KRAS G12D non‑small cell lung cancer (NSCLC). The results were presented at AACR 2026 (Abstract # CT021) and focus on safety and early signs of anti‑tumor activity in this hard‑to‑treat subgroup.
The company reported encouraging clinical activity, with objective responses and disease control observed in a subset of heavily pretreated patients. Responses showed duration in some cases, and the overall safety profile was described as manageable, with most adverse events being low to moderate in severity. These findings suggest the drug can hit its intended target and produce meaningful benefit for some patients.
Revolution Medicines plans to continue enrolling patients, refine dosing, and evaluate zoldonrasib in additional studies and potential combination regimens to better define its role in KRAS G12D NSCLC treatment.Read Announcement
- Drug:
- Zoldonrasib
- Announced Date:
- March 17, 2026
- Indication:
- for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC
Announcement
Revolution Medicines, Inc announced that nine oral and poster presentations highlighting advances across its RAS(ON) inhibitor pipeline will be featured at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17–22, 2026 in San Diego.
AI Summary
Revolution Medicines announced nine oral and poster presentations at the American Association for Cancer Research (AACR) Annual Meeting, April 17–22, 2026 in San Diego, highlighting advances across its RAS(ON) inhibitor pipeline.
The presentations include new Phase 1 data for zoldonrasib, a RAS(ON) G12D-selective inhibitor, in patients with previously treated KRAS G12D mutant non‑small cell lung cancer; this data will be featured in a plenary session. The company will also present two Phase 1/2 datasets for daraxonrasib, a RAS(ON) multi‑selective inhibitor, in first‑line metastatic pancreatic ductal adenocarcinoma (PDAC): monotherapy results and daraxonrasib plus chemotherapy combination data, with the combination shown in a mini‑symposium. Additional talks and posters will describe preclinical work on a new class of mutant‑targeted catalytic RAS(ON) inhibitors designed to retain antitumor activity against emergent resistance.
Taken together, these presentations span clinical and discovery efforts and underscore the company’s strategy to address resistance and expand treatment options for patients with RAS‑driven cancers.
Read Announcement- Drug:
- Zoldonrasib
- Announced Date:
- January 8, 2026
- Indication:
- for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC
Announcement
Revolution Medicines, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to zoldonrasib, a RAS(ON) G12D-selective inhibitor, for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.
AI Summary
Revolution Medicines announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to zoldonrasib, a RAS(ON) G12D-selective inhibitor, for adults with KRAS G12D‑mutated locally advanced or metastatic non‑small cell lung cancer (NSCLC) who were previously treated with anti‑PD‑1/PD‑L1 therapy and platinum‑based chemotherapy.
The designation is based on results from the monotherapy cohort of the Phase 1 RMC‑9805‑001 trial, which showed a robust clinical profile with encouraging anti‑tumor activity and acceptable safety and tolerability. Zoldonrasib is a tri‑complex covalent inhibitor that binds cyclophilin A to selectively recognize and inhibit the active, oncogenic RAS G12D(ON) mutant.
Breakthrough Therapy status is meant to speed development and review for treatments that address serious unmet needs and show early evidence of substantial improvement over available options. KRAS G12D is an important oncogenic driver in NSCLC and currently lacks approved targeted therapies.
Read Announcement
Elironrasib FDA Regulatory Events
Elironrasib is a drug developed by Revolution Medicines for the following indication: for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic 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:
- elironrasib
- Announced Date:
- October 22, 2025
- Indication:
- for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
Announcement
Revolution Medicines, Inc. announced updated clinical data for elironrasib, a RAS(ON) G12C-selective inhibitor, in previously treated patients with KRAS G12C non-small cell lung cancer (NSCLC) who had received a prior KRAS(OFF) G12C inhibitor.
AI Summary
Revolution Medicines, Inc. announced updated clinical data for elironrasib, a RAS(ON) G12C-selective inhibitor, in patients with KRAS G12C non-small cell lung cancer (NSCLC) who had progressed on prior KRAS(OFF) G12C inhibitors.
As of August 4, 2025, twenty-four heavily pretreated NSCLC patients received elironrasib at 200 mg twice daily. They had a median of three prior therapies and 92% had progressed on a KRAS(OFF) G12C inhibitor. Elironrasib achieved a 42% confirmed objective response rate and a 79% disease control rate, with a median response duration of 11.2 months. Median progression-free survival was 6.2 months, and the 12-month overall survival rate was 62%. The treatment was generally well tolerated.
These findings demonstrate elironrasib’s ability to overcome resistance to first-generation G12C inhibitors and support further studies of this targeted therapy, both alone and in combination, for KRAS G12C NSCLC.
Read Announcement- Drug:
- elironrasib
- Announced Date:
- July 23, 2025
- Indication:
- for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
Announcement
Revolution Medicines, 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.
AI Summary
Revolution Medicines announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to elironrasib, a RAS(ON) G12C-selective inhibitor, for treating adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who previously received chemotherapy and immunotherapy but no KRAS G12C inhibitor.
This designation is based on data from the Phase 1 RMC-6291-001 trial, where elironrasib monotherapy showed strong antitumor activity, a favorable safety profile, and encouraging objective response rates and progression-free survival in patients with advanced KRAS G12C solid tumors.
Elironrasib works by binding selectively and covalently to the active form of the KRAS G12C protein, which drives about 12 percent of NSCLC cases. Revolution Medicines is exploring elironrasib both alone and in combination with other therapies.
Non-small cell lung cancer makes up 80–85 percent of lung cancers. Nearly 30 percent of these tumors carry KRAS mutations, with G12C being the most common. No RAS-targeted therapy has full FDA approval for KRAS G12C NSCLC, highlighting the unmet need this designation aims to address.
Read Announcement
RASolve 301 FDA Regulatory 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.
Read Announcement
RMC-9805 FDA Regulatory 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.
Read Announcement
RMC-6236 FDA Regulatory 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
- 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.
Read Announcement
Free RVMD Stock Alerts