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 and onvansertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CRDF-004 - FDA Regulatory Timeline and Events
CRDF-004 is a drug developed by Cardiff Oncology for the following indication: RAS-mutated mCRC.
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 15, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- Indication:
- RAS-mutated mCRC.
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:
- RAS-mutated mCRC.
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
- Indication:
- RAS-mutated mCRC.
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- Drug:
- CRDF-004
- Announced Date:
- December 10, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- Indication:
- RAS-mutated mCRC.
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
onvansertib + paclitaxel - FDA Regulatory Timeline and 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
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