bicalutamide
bicalutamide: developed by 1 company · 11 clinical trials tracked · 1 FDA decision.
bicalutamide evidence translation
What we can confirm
1 FDA record · 11 tracked trials
What it means
What to watch
Prepared research question
How could bicalutamide → AZN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 3 study sponsors
Development Pipeline (2)
| Company | Phase |
|---|---|
| ASTRAZENECA PLC (AZN) | Approved |
| ASTRAZENECA PLC (AZN) | Approved |
Clinical Trials (11)showing 10 most recent
Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 Trial
Primary endpoint: Incidence of ambulatory systolic blood pressure (BP) > 140 or diastolic > 90 (measurement on 2 separate days)
A Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
Primary endpoint: Number of participants with disease control at 16 weeks
Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)
Primary endpoint: Distant metastasis (DM) (De-intensification study)
Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)
Primary endpoint: Metastasis-free survival (MFS)
The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
Primary endpoint: Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration
STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features
Primary endpoint: Percentage of Participants Alive Without Progression (Progression-Free Survival)
A Phase II Study of Nivolumab Combined With Bicalutamide and Ipilimumab in Metastatic HER2-negative Breast Cancer
Primary endpoint: iRECIST Clinical Benefit Rate (the number of patients with objective response or ongoing stable disease at week 24 using iRECIST guidelines)
Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel
Primary endpoint: Freedom from progression (FFP) (Phase II)
ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy
Primary endpoint: Metastasis-Free Survival (MFS)
A Randomized Study of Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone in Patients With Prostate Cancer Who Have PSA Progression After Prostatectomy and/or Radiotherapy
Primary endpoint: Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml)
FDA Decisions1 records
Frequently asked questions
Who is developing bicalutamide?
bicalutamide is being developed by ASTRAZENECA PLC.
How many clinical trials involve bicalutamide?
BioSniper tracks 11 clinical trials involving bicalutamide.
What is bicalutamide's latest FDA decision?
The most recent tracked FDA decision for bicalutamide is Approval for 1. INDICATIONS AND USAGE CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • CASODEX 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stag, dated December 19, 2008.