This section highlights FDA-related milestones and regulatory updates for drugs developed by Veracyte (VCYT).
Over the past two years, Veracyte has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
STAMPEDE and VANDAAM. 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.
STAMPEDE FDA Regulatory Events
STAMPEDE is a drug developed by Veracyte for the following indication: In Patients with Metastatic Prostate 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:
- STAMPEDE
- Announced Date:
- August 27, 2025
- Indication:
- In Patients with Metastatic Prostate Cancer
Announcement
Veracyte, Inc announced that data published online in Cell show that the Decipher Prostate Genomic Classifier predicts which patients with metastatic cancer are likely to benefit from treatment intensification with the chemotherapy docetaxel and which are not likely to benefit and can therefore avoid unnecessary toxicity.
AI Summary
Veracyte, Inc. and University College London reported online in Cell that the Decipher Prostate Genomic Classifier can guide chemotherapy decisions for men with metastatic prostate cancer. In the Phase 3 STAMPEDE trial, researchers tested 1,523 patients, including 832 with metastatic disease, and followed them for 14 years. They found that patients with high Decipher scores had a clear survival benefit from adding docetaxel to standard hormone therapy, while those with low scores did not benefit and could avoid the extra toxicity.
This study is the first to show a gene expression test predicting who will gain from treatment intensification. Results were consistent regardless of disease volume, offering a new tool to personalize care. Veracyte now makes the Decipher test broadly available in the U.S. for metastatic cases. Clinicians can use the test to decide which patients should receive chemotherapy plus hormone therapy and which can safely skip docetaxel side effects.
Read Announcement- Drug:
- STAMPEDE
- Announced Date:
- September 15, 2024
- Indication:
- In Patients with Metastatic Prostate Cancer
Announcement
Veracyte, Inc announced that new data from a phase 3 trial of the multi-center, randomized STAMPEDE clinical trial show that its Decipher Prostate Genomic Classifier is prognostic for clinical outcomes and predicts benefit from docetaxel in patients with metastatic prostate cancer.
AI Summary
Veracyte, Inc. announced new data from the phase 3 STAMPEDE clinical trial showing that its Decipher Prostate Genomic Classifier is not only prognostic for clinical outcomes but also predicts which patients with metastatic prostate cancer benefit from docetaxel chemotherapy. The study followed 1,523 patients for a median of 14 years and found that those with higher Decipher scores had a greater risk of death. Notably, among 832 metastatic patients, only those with higher scores had a significant survival benefit from adding docetaxel to standard androgen deprivation therapy.
This breakthrough supports Veracyte’s plan to expand the use of the Decipher Prostate test, which is already used for localized disease, to a broader group of patients with metastatic prostate cancer, potentially helping doctors make more personalized treatment decisions and avoid unnecessary chemotherapy toxicities.
Read Announcement
VANDAAM Study FDA Regulatory Events
VANDAAM Study is a drug developed by Veracyte for the following indication: Physicians tailor treatment decisions for men with prostate 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:
- VANDAAM Study
- Announced Date:
- October 2, 2024
- Indication:
- Physicians tailor treatment decisions for men with prostate cancer
Announcement
Veracyte, Inc announced that new data from the multicenter, prospective VANDAAM trial show that the Decipher Prostate Genomic Classifier accurately predicts aggressive prostate cancer among African American men with early-stage disease.
AI Summary
Veracyte, Inc. announced new data from the prospective, multicenter VANDAAM trial demonstrating that the Decipher Prostate Genomic Classifier accurately predicts aggressive prostate cancer in African American men with early-stage disease. In this trial, African American patients were carefully matched with non-African American counterparts based on similar clinical factors. The study showed that the genomic classifier effectively identifies patients at a higher risk of a rapid recurrence of prostate cancer, offering a significant improvement over traditional clinical assessments alone. Given that African American men face higher diagnosis and mortality rates from prostate cancer, these findings are particularly important. They suggest that using the Decipher Prostate test could enable more personalized treatment decisions and help reduce disparities in outcomes. The results, presented at the ASTRO 2024 meeting, mark an important step forward in tailoring prostate cancer care for African American men.
Read Announcement
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