BEIZRAY (docetaxel)
BEIZRAY is indicated for the treatment of Breast Cancer; Non-Small Cell Lung Cancer; Castration-Resistant Prostate Cancer; Gastric Adenocarcinoma; Squamous Cell Carcinoma of the Head and Neck.
Details
- Status
- Prescription
- First Approved
- 2024-10-23
- Patent Cliff
- 2036
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
BEIZRAY Approval History
What BEIZRAY Treats
5 indicationsBEIZRAY is approved for 5 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
- Non-Small Cell Lung Cancer
- Castration-Resistant Prostate Cancer
- Gastric Adenocarcinoma
- Squamous Cell Carcinoma of the Head and Neck
BEIZRAY Boxed Warning
TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with BEIZRAY is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non- small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive BEIZRAY as a single agent at a dose of 100 mg/m 2 [ see Warnings and Precautions ( 5.1 ) ] . Avoid the use of BEIZRAY in patients with b...
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with BEIZRAY is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non- small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive BEIZRAY as a single agent at a dose of 100 mg/m 2 [ see Warnings and Precautions ( 5.1 ) ] . Avoid the use of BEIZRAY in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 × ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of BEIZRAY [ see Warnings and Precautions ( 5.2 ) ] . Do not administer BEIZRAY to patients with neutrophil counts of <1500 cells/mm 3 . Monitor blood counts frequently as neutropenia may be severe and result in infection. [ see Warnings and Precautions ( 5.3 ) ] . Do not administer BEIZRAY to patients who have a history of severe hypersensitivity reactions to docetaxel [see Contraindications (4) ] . Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the BEIZRAY infusion and administration of appropriate therapy [see Warnings and Precautions ( 5.5 )] . Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generaliz
BEIZRAY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BEIZRAY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BEIZRAY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BEIZRAY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
801 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04310007 | NCI-2020-01541 NCI-2020-01541, EA5191 | Ph 2 | active not recruiting | Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer |
| NCT06498648 | NCI-2024-05665 NCI-2024-05665, 10657 | Ph 1, Ph 2 | recruiting | Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma |
| NCT06445400 | BL-M07D1-205 | Ph 2 | active not recruiting | A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer |
| NCT01810913 | NCI-2013-00500 NCI-2013-00500, RTOG-1216 | Ph 2, Ph 3 | recruiting | Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer |
| NCT04579224 | NCI-2020-07651 NCI-2020-07651, S1937 | Ph 3 | active not recruiting | Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer |
| NCT04928846 | M18-868 2023-505749-14-00 | Ph 3 | recruiting | A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) |
| NCT06524544 | NCI-2024-06208 NCI-2024-06208, EA8231 | Ph 3 | recruiting | A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer |
| NCT05063552 | NCI-2021-10021 NCI-2021-10021, EA3202 | Ph 2, Ph 3 | active not recruiting | Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers |
| NCT05836584 | NCI-2023-03192 NCI-2023-03192, EA2212 | Ph 2 | active not recruiting | Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer |
| NCT03337698 Morpheus Lung results posted | BO39610 2017-001267-21 | Ph 1, Ph 2 | terminated | A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) |
| NCT05541016 | GMROR2271 22-004443, DART 2.0 | Ph 2 | recruiting | De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA |
| NCT06074588 | 2870-004 2023-503539-16-00, jRCT2031240108 | Ph 3 | active not recruiting | Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004) |
| NCT03390504 THOR results posted | CR108401 42756493BLC3001, 2017-002932-18 | Ph 3 | active not recruiting | A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations |
| NCT07225946 KLK2-PASenger | 78278343PCR3003 78278343PCR3003, 2025-522713-29-00 | Ph 3 | recruiting | A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer |
| NCT06929286 | 25-069 | Ph 3 | recruiting | A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC) |
| NCT07213674 | 20230239 | Ph 3 | recruiting | A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer |
| NCT05319873 | 21-001819 NCI-2021-11707 | Ph 1, Ph 2 | active not recruiting | Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer |
| NCT06931340 | A032302 NCI-2025-00838 | Ph 3 | recruiting | Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial |
| NCT06925737 | 2400-001 U1111-1312-2498, 2024-517423-40-00 | Ph 3 | recruiting | A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) |
| NCT06632327 | CTIU2317-A082304-S2402 NCI-2024-06356 | Ph 3 | recruiting | Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer |
| NCT05954312 | VVD-130037-001 2023-506199-28-00 | Ph 1 | recruiting | A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors |
| NCT06545955 ABLE-22 | 000434 U1111-1299-0176 | Ph 3 | recruiting | A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer |
| NCT05631262 | SKB264-Ⅱ-08 | Ph 2 | active not recruiting | SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors |
| NCT05818683 | CR109321 78278343PCR1003, 2022-503132-14-00 | Ph 1 | recruiting | A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer |
| NCT06952504 TroFuse-033 | 2870-033 2024-519331-42-00, U1111-1315-0794 | Ph 3 | recruiting | A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29) |
| NCT07419295 TroFuse-031 | 2870-031 U1111-1316-4390, 2024-520014-22-00 | Ph 3 | recruiting | A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) |
| NCT06863272 | 2400-01A MK-2400-01A, 2024-516036-94-00 | Ph 1, Ph 2 | recruiting | A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02) |
| NCT03070886 | NRG-GU002 NCI-2016-00963, NRG-GU002 | Ph 2, Ph 3 | completed | Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery |
| NCT05089734 EVOKE-01 results posted | GS-US-577-6153 jRCT2051220119, 2024-512148-50 | Ph 3 | active not recruiting | Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) |
| NCT03801876 | NRG-GI006 NCI-2018-03378, NRG-GI006 | Ph 3 | recruiting | Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer |
| NCT07220135 NeoTHERa | IIT-2025-NeoTHERa | Ph 2 | recruiting | Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer |
| NCT06764485 rechARge | CA071-1000 2024-517422-25, U1111-1311-0532 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer |
| NCT06989112 DE-01 | D781DC00001 2023-508056-19-00, GOG-3098 | Ph 3 | recruiting | DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer |
| NCT07287150 InavoPC | CO45813 2025-521327-67-00 | Ph 2 | recruiting | A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer |
| NCT05173987 | 3475-C93 MK-3475-C93, KEYNOTE-C93 | Ph 3 | active not recruiting | Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) |
| NCT06616584 | S1800E NCI-2024-06444, S1800E | Ph 2, Ph 3 | recruiting | Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial) |
| NCT03493425 | EA3163 NCI-2017-01364, EA3163 | Ph 2 | recruiting | Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery |
| NCT05538663 BRIDGE | EA8212 U10CA180820, NCI-2022-04864 | Ph 3 | active not recruiting | Intravesical BCG vs GEMDOCE in NMIBC |
| NCT06520345 | 177Lu-TLX591-203 | Ph 3 | recruiting | The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global) |
| NCT06745908 | ResQ201A-NSCLC | Ph 3 | recruiting | Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In |
| NCT05083481 | 1570-CL-0101 jRCT2031220527, KEYNOTE-E59 | Ph 1, Ph 2 | active not recruiting | A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors |
| NCT06635824 | GCT1046-06 2024-512998-27-00, jRCT2051240178 | Ph 3 | active not recruiting | Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) |
| NCT04266249 | EA1181 NCI-2019-07439, EA1181 | Ph 2 | active not recruiting | CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy |
| NCT07365995 | BNT324-03 2025-524445-27-00 | Ph 3 | recruiting | A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer |
| NCT06551324 MEVPRO-1 | C2321014 2024-511650-50-00 | Ph 3 | active not recruiting | A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). |
| NCT03740165 results posted | 7339-001 ENGOT-ov43, MK-7339-001 | Ph 3 | completed | Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036) |
| NCT05408845 | NRG-HN010 NCI-2022-04353, NRG-HN010 | Ph 2 | recruiting | Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers |
| NCT07566052 | 3082-CL-5301 | Ph 3 | not yet recruiting | A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation |
| NCT00588770 results posted | NCI-2009-00507 NCI-2009-00507, E1305 | Ph 3 | active not recruiting | Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma |
| NCT02642042 results posted | NCI-2015-02250 NCI-2015-02250, S1507 | Ph 2 | active not recruiting | Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer |
Showing 50 of 801 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BEIZRAY FDA Label Details
Indications & Usage
FDA Label (PDF)BEIZRAY is indicated for the treatment of Breast Cancer; Non-Small Cell Lung Cancer; Castration-Resistant Prostate Cancer; Gastric Adenocarcinoma; Squamous Cell Carcinoma of the Head and Neck.
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with BEIZRAY is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non- small cell lung carcinoma and a...
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Revenue Insights
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Patent Timeline
- • Cliff: 2036
- • 11 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.