This section highlights FDA-related milestones and regulatory updates for drugs developed by Cardiff Oncology (CRDF).
Over the past two years, Cardiff Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CRDF-004, Onvansertib, and onvansertib. 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.
CRDF-004 FDA Regulatory Timeline and Events
CRDF-004 is a drug developed by Cardiff Oncology for the following indication: .
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:
- CRDF-004
- Announced Date:
- April 21, 2026
- Indication:
Announcement
Cardiff Oncology, Inc. announced it will present updated data from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).
AI Summary
Cardiff Oncology announced it will present updated, interim results from CRDF-004, a randomized dose-finding Phase 2 trial testing onvansertib combined with standard-of-care chemotherapy plus bevacizumab (FOLFIRI/bevacizumab or FOLFOX/bevacizumab) in patients with first-line RAS‑mutated metastatic colorectal cancer (mCRC). The study is designed to evaluate dosing and activity of onvansertib alongside accepted chemotherapy backbones in newly diagnosed metastatic patients with RAS mutations.
The rapid oral presentation is titled “Onvansertib plus standard-of-care chemotherapy plus bevacizumab in first-line RAS-mutated metastatic colorectal cancer (mCRC): Interim results from the phase 2 randomized CRDF-004 trial” (Abstract No. 3510) and will be presented in the Gastrointestinal Cancer—Colorectal and Anal session on June 2, 2026, 8:00–9:30 AM CDT. The abstract will be posted on ASCO’s website on May 21, 2026, and the company will post the presentation on its Scientific Publications page after the session.
Onvansertib is a selective oral PLK1 inhibitor in mid-stage development for RAS‑mutated mCRC and is also being studied in other cancers through investigator‑initiated trials, including pancreatic, small cell lung, triple‑negative breast cancers, and CMML.
Read Announcement- Drug:
- CRDF-004
- Announced Date:
- January 27, 2026
- Indication:
Announcement
Cardiff Oncology, Inc. announced a positive update from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line (1L) RAS-mutated metastatic colorectal cancer (mCRC).
AI Summary
Cardiff Oncology reported positive Phase 2 CRDF-004 results for onvansertib added to first-line FOLFIRI/bevacizumab (bev) or FOLFOX/bev in patients with RAS‑mutated metastatic colorectal cancer (mCRC). In an intent‑to‑treat analysis, onvansertib produced dose‑dependent benefits: higher objective response rates and trends toward more durable disease control measured by progression‑free survival (PFS). The 30 mg onvansertib plus FOLFIRI/bev arm performed best versus standard‑of‑care arms and versus the FOLFOX/bev combination, achieving a statistically significant PFS benefit versus pooled SoC and showing numerically higher response rates.
The drug was well tolerated with no unexpected additive toxicities; grade 3+ events were infrequent, neutropenia being most common. Based on these data, Cardiff selected 30 mg onvansertib with FOLFIRI/bev for a planned registrational program and expects to provide final data and registrational plans in the first half of 2026. The company hosted a conference call to discuss the results.
Read Announcement- Drug:
- CRDF-004
- Announced Date:
- July 29, 2025
- Indication:
Announcement
Cardiff Oncology, Inc. announced positive data from the ongoing CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).
AI Summary
Cardiff Oncology announced positive results from its Phase 2 CRDF-004 trial testing onvansertib plus standard chemotherapy in first-line RAS-mutated metastatic colorectal cancer. In 110 patients, the 30 mg onvansertib arm achieved a 49% confirmed objective response rate (ORR) versus 30% in the control arm. The 20 mg dose arm showed a 42% ORR. Early progression-free survival data also trended in favor of the 30 mg dose. Onvansertib was well tolerated, with few grade 3 or higher side effects, and showed dose-dependent benefits across ORR, early tumor shrinkage, and depth of response.
The randomized trial paired onvansertib with FOLFIRI or FOLFOX plus bevacizumab and used blinded central review to assess outcomes. Beyond ORR, secondary endpoints include progression-free survival, duration of response, and safety. Cardiff Oncology will discuss these findings on a conference call today at 4:30 p.m. ET (1:30 p.m. PT).
Read Announcement- Drug:
- CRDF-004
- Announced Date:
- April 15, 2025
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
Announcement
Cardiff Oncology, Inc. announced that Additional clinical data from CRDF-004 trial expected in 1H 2025
AI Summary
Cardiff Oncology, Inc. announced that it has completed patient enrollment in its Phase 2 CRDF-004 trial, which examines onvansertib in combination with standard care for first-line treatment of RAS-mutated metastatic colorectal cancer. The trial, conducted across 41 clinical sites in the U.S., focuses on patients with documented KRAS or NRAS mutations and unresectable disease. The study assesses the effectiveness of adding onvansertib to standard care regimens that include FOLFIRI or FOLFOX plus bevacizumab.
The company expects to report additional clinical data from the CRDF-004 trial in the first half of 2025. According to Cardiff Oncology’s CEO, this milestone is significant for advancing treatment options in a patient population that has long awaited new therapies. The forthcoming data will be key for future regulatory discussions and the development of potentially transformative treatment strategies.
Read Announcement- Drug:
- CRDF-004
- Announced Date:
- April 15, 2025
- Indication:
Announcement
Cardiff Oncology, Inc. announced completion of patient enrollment in the ongoing Phase 2 CRDF-004 trial evaluating onvansertib in combination with standard of care (SoC) for the treatment of first-line RAS-mutated metastatic colorectal cancer (mCRC).
AI Summary
Cardiff Oncology, Inc. has reached an important milestone by completing patient enrollment in its ongoing Phase 2 CRDF-004 trial. The study is evaluating onvansertib in combination with standard of care (SoC) for treating first-line RAS-mutated metastatic colorectal cancer (mCRC). Patients with documented KRAS or NRAS mutations are being treated across 41 U.S. clinical sites. In the trial, onvansertib is added to SoC—which includes regimens such as FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab—with patients receiving either 20mg or 30mg doses, or SoC alone.
The primary endpoint is the objective response rate, with additional measures including progression-free survival, duration of response, and safety. Cardiff Oncology is now focused on collecting further clinical data and is preparing for future regulatory discussions, aiming to bring this potential new treatment option to patients who have had limited advancements in therapy for decades.
Read Announcement- Drug:
- CRDF-004
- Announced Date:
- December 10, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
Announcement
Cardiff Oncology Announced that Additional clinical data from CRDF-004 trial expected in 1H 2025 -
AI Summary
Cardiff Oncology has announced that additional clinical data from its Phase 2 CRDF-004 trial is expected in the first half of 2025. This trial evaluates onvansertib in combination with standard treatments in patients with RAS-mutated metastatic colorectal cancer. Initial results from the trial have been promising, showing that patients receiving a 30mg dose of onvansertib experienced a significantly higher objective response rate and deeper tumor regression compared to the control group.
The upcoming data release in 1H 2025 is highly anticipated, as it is expected to provide further insights into the safety and efficacy of onvansertib when used alongside existing standard-of-care therapies. Cardiff Oncology believes that these additional results could support the potential of onvansertib to improve treatment outcomes for patients facing this challenging form of cancer.
Read Announcement- Drug:
- CRDF-004
- Announced Date:
- December 10, 2024
- Indication:
Announcement
Cardiff Oncology, Inc. announced positive initial data from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).
AI Summary
Cardiff Oncology, Inc. announced encouraging early results from its randomized Phase 2 CRDF-004 trial, which evaluated onvansertib in combination with standard-of-care (SoC) for patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). The trial compared two doses of onvansertib, revealing that the 30mg dose achieved a 64% objective response rate (ORR), significantly higher than the 33% ORR observed with SoC alone. The 30mg dose also showed deeper tumor regression compared to the 20mg dose, which had a 50% ORR. Importantly, onvansertib was well tolerated at both doses, with no major unexpected toxicities reported. These promising results support onvansertib’s potential to improve outcomes for RAS-mutated mCRC patients. Cardiff Oncology plans to release additional clinical data from the CRDF-004 trial in the first half of 2025.
Read Announcement
Onvansertib Monotherapy FDA Regulatory Events
Onvansertib Monotherapy is a drug developed by Cardiff Oncology for the following indication: 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:
- Onvansertib Monotherapy
- Announced Date:
- March 19, 2026
- Indication:
- Small cell lung cancer
Announcement
Cardiff Oncology, Inc. announced that new preclinical data highlighting the potential of its highly specific oral PLK1 inhibitor, onvansertib, in combination with trastuzumab deruxtecan (T-DXd) will be presented at the American Association for Cancer Research Annual Meeting 2026, taking place April 17-22, 2026 in San Diego, California.
AI Summary
Cardiff Oncology announced new preclinical data showing its oral PLK1 inhibitor onvansertib boosted the antitumor activity of trastuzumab deruxtecan (T-DXd) and reversed resistance in therapy-resistant HER2-low breast cancer models. These results will be presented as a poster at the American Association for Cancer Research Annual Meeting 2026, April 17–22 in San Diego, California. The poster will be posted on the company’s Scientific Publications page after the presentation.
Onvansertib is a highly specific, oral PLK1 inhibitor in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in investigator-initiated studies for metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, triple-negative breast cancer, and chronic myelomonocytic leukemia. The preclinical findings suggest onvansertib may help overcome resistance to T-DXd and improve responses in HER2-low breast tumors, supporting a combination strategy.
Read Announcement- Drug:
- Onvansertib Monotherapy
- Announced Date:
- December 8, 2025
- Indication:
- Small cell lung cancer
Announcement
Cardiff Oncology, Inc. announced that clinical data from an investigator-sponsored trial with onvansertib in chronic myelomonocytic leukemia (CMML) will be presented in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting.
AI Summary
Cardiff Oncology announced that clinical data from an investigator‑sponsored Phase 1 trial of onvansertib in chronic myelomonocytic leukemia (CMML) will be presented as a poster at the 67th American Society of Hematology (ASH) Annual Meeting.
In this dose‑escalation trial (N=9), onvansertib given alone was relatively well tolerated and showed preliminary efficacy in about 40% of patients. One patient achieved an optimal marrow response at the 9 mg/m2 dose. Cardiff noted these results support single‑agent activity of onvansertib in a hematologic cancer and are consistent with prior investigator‑sponsored findings in small cell lung cancer.
Cardiff said it is not currently planning to develop onvansertib for CMML. The poster, titled “Phase 1 clinical trial assessing the safety and efficacy of onvansertib… in relapsed/refractory myeloproliferative CMML,” will be presented by Mrinal Patnaik, MD, at a poster session on December 8, 2025; the abstract is on the ASH meeting website.
Read Announcement
Onvansertib + paclitaxel FDA Regulatory Events
Onvansertib + paclitaxel is a drug developed by Cardiff Oncology for the following indication: In Metastatic Triple-Negative Breast 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:
- onvansertib + paclitaxel
- Announced Date:
- June 2, 2025
- Indication:
- In Metastatic Triple-Negative Breast Cancer
Announcement
Cardiff Oncology, Inc. announced positive data from an investigator-initiated Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel in patients with metastatic triple-negative breast cancer (mTNBC) at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30-June 3, 2025, in Chicago, Illinois.
AI Summary
Cardiff Oncology, Inc. announced positive results from an investigator-initiated Phase 1b clinical trial evaluating the combination of onvansertib and paclitaxel in patients with metastatic triple-negative breast cancer (mTNBC). The trial, presented at the ASCO Annual Meeting in Chicago from May 30 to June 3, 2025, demonstrated a 40% objective response rate at the highest dose of onvansertib, highlighting a promising dose-response relationship. The study enrolled heavily pretreated mTNBC patients, many of whom had previous exposure to paclitaxel, and the majority experienced partial responses, with two confirmed and two unconfirmed responses observed.
The combination therapy was well-tolerated with a manageable safety profile, primarily showing myelosuppression as the most common adverse event. These results provide clinical validation for the synergistic potential of onvansertib with paclitaxel, offering hope for improved treatment options in this aggressive subtype of breast cancer.
Read Announcement
