GVAX Receives Fast-Track Status

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 15 No 6
Volume 15
Issue 6

The FDA has granted Cell Genesys' GVAX immunotherapy fast track designation for prostate cancer. Two independent phase II trials in patients with hormone-refractory metastatic prostate cancer showed that median survival with GVAX compared favorably with that of patients treated with standard docetaxel (Taxotere)/prednisone in previous studies, the company said. Two phase III trials of GVAX have been initiated, VITAL-1 and VITAL-2. Each will enroll approximately 600 patients.

SOUTH SAN FRANCISCO, Calif—The FDA has granted Cell Genesys' GVAX immunotherapy fast track designation for prostate cancer. Two independent phase II trials in patients with hormone-refractory metastatic prostate cancer showed that median survival with GVAX compared favorably with that of patients treated with standard docetaxel (Taxotere)/prednisone in previous studies, the company said. Two phase III trials of GVAX have been initiated, VITAL-1 and VITAL-2. Each will enroll approximately 600 patients.

Articles in this issue
Triple-Negative Cancers More Common in Young Black Pts
Artists Turn Flowers & Curves Into 'Forms' and 'Figures'
Study to Examine Outcomes Disparities in Pediatric ALL
Thalidomide Has 'Changed the Paradigm' in Myeloma Rx
CA4P Gets Orphan Drug Status
Testicular Ca Survivors at Increased Risk for CV Events
A Novel Brings a Cancer Research Laboratory to Life
NCCN Reveals New Venous Thromboembolism Guideline
Lapatinib New Option for Metastatic HER2+ Breast Ca
FDA Approves Dacogen for Treating All MDS Subtypes
Noninvasive Ablation Relieves Chronic Chest Wall Pain
GVAX Receives Fast-Track Status
Medicare CAP Vendor Selected
Selective IGF-1R Inhibitor Blocks Colon Cancer Growth
US Cancer Mortality Drops

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Subscribe Now!
Recent Videos
4 experts in this video
4 experts in this video
1 expert in this video
1 expert in this video
1 expert in this video
Multidisciplinary collaboration may help in minimizing the treatment burden among patients with prostate cancer, according to Curtiland Deville Jr., MD.
4 experts in this video
Related Content
Landmark Radioligand Therapy Approval Bridges Treatment Gap in mCRPC

Landmark Radioligand Therapy Approval Bridges Treatment Gap in mCRPC

Ariana Pelosci
April 18th 2025
Article

Administering 177Lu for mCRPC is a “team sport”, according to Steven Finkelstein, MD, DABR, FACRO.

Navigating Treatment Intensification in Metastatic Hormone-Sensitive Prostate Cancer

Navigating Treatment Intensification in Metastatic Hormone-Sensitive Prostate Cancer

Manojkumar Bupathi, MD, MS;Benjamin Garmezy, MD;David Morris, MD, MS;Tanya B. Dorff, MD;Mark T. Fleming, MD
March 5th 2025
Podcast

A patient case of a 50-year-old man with hormone-sensitive prostate cancer sparked a debate among oncologists regarding the best course of action.

Pembrolizumab/Docetaxel Does Not Improve OS/rPFS Outcomes in mCRPC

Pembrolizumab/Docetaxel Does Not Improve OS/rPFS Outcomes in mCRPC

Tim Cortese
April 15th 2025
Article

Results from the KEYNOTE-921 trial demonstrated that pembrolizumab with docetaxel did not elicit efficacy improvements vs placebo with docetaxel in prostate cancer.

AI tools may show utility in areas such as prostate diagnostic imaging, pathology, and treatment outcome predictions.

Leveraging Artificial Intelligence Evolutions in Prostate Cancer Care

James B. Yu, MD, MHS, FASTRO;Julian C. Hong, MD, MS
July 1st 2024
Podcast

AI tools may show utility in areas such as prostate diagnostic imaging, pathology, and treatment outcome predictions.

Results from PSMAfore show that lutetium Lu 177 vipivotide tetraxetan elicited a median rPFS of 9.3 months vs 5.6 months with ARPI in prostate cancer.

FDA Approves Radioligand Therapy in PSMA–Positive, Castration-Resistant PC

Tim Cortese
March 28th 2025
Article

Results from PSMAfore show that lutetium Lu 177 vipivotide tetraxetan elicited a median rPFS of 9.3 months vs 5.6 months with ARPI in prostate cancer.

Post-Radical Prostatectomy PSA Levels Reduced Overtreatment Risk After 3 Months

Post-Radical Prostatectomy PSA Levels Reduced Overtreatment Risk After 3 Months

Tim Cortese
March 26th 2025
Article

A cohort study found that pre-radical prostatectomy levels greater than 20 ng/mL were associated with increased all-cause mortality risk and prostate cancer-specific mortality risk.