PACLITAXEL · MSN
Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES,...
Details
- Status
- Prescription
- First Approved
- 1992-12-29
- PDUFA Date
- 2026-07-11 (0d)
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, POWDER
Companies
PACLITAXEL Approval History
What PACLITAXEL Treats
21 FDA approvalsOriginally approved for its first indication in 2002 . Covers 21 distinct patient populations.
- Other (21)
Other
(21 approvals)- • Approved indication (Jan 2002)Label Letter
- • Approved indication (Jan 2002)Letter
- • Approved indication (May 2002)
- • Approved indication (Aug 2002)
- • Approved indication (Nov 2004)
- • Approved indication (Nov 2006)
- • Approved indication (Dec 2007)
- • Approved indication (Mar 2008)
- • Approved indication (Dec 2009)
- • Approved indication (Sep 2011)
- • Approved indication (Aug 2016)
- • Approved indication (Aug 2018)
- • Approved indication (Aug 2020)
- • Approved indication (Jul 2022)Label Letter
- • Approved indication (Oct 2022)
- • Approved indication (May 2023)Label Letter
- • Approved indication (Nov 2023)Label Letter
- • Approved indication (Oct 2024)
- • Approved indication (Apr 2025)
- • Approved indication (May 2025)
- • Approved indication (Aug 2025) New
PACLITAXEL Boxed Warning
WARNING Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal...
WARNING Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists (see DOSAGE AND ADMINISTRATION ). Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1,500 cells/mm 3 and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1,000 cells/mm 3 . In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving paclitaxel.
Clinical Trial Registry
1283 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03604991 | NCI-2018-01575 NCI-2018-01575, EA2174 | Ph 2, Ph 3 | suspended | Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery |
| NCT07396324 NEO-ITHRAN | LY2025-422-A | Ph 2 | recruiting | Neoadjuvant QL1706 in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer |
| 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 |
| NCT06058377 | NCI-2023-04566 NCI-2023-04566, S2206 | Ph 3 | recruiting | Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer |
| NCT07198074 | NCI-2025-06974 NCI-2025-06974, NRG-GY035 | Ph 3 | recruiting | Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer |
| NCT07281417 | NCI-2025-09016 NCI-2025-09016, 10721 | Ph 2 | recruiting | Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma |
| NCT05019716 | NCI-2021-08926 NCI-2021-08926, 10507 | Ph 1, Ph 2 | recruiting | Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma |
| NCT07221474 INTerpath-13 | V940-013 V940-013, U1111-1318-2495 | Ph 2 | recruiting | A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) |
| NCT07283692 | LY2025-277-A | Ph 2 | recruiting | Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT) |
| 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 |
| NCT01081951 results posted | D0810C00041 2009-015970-36 | Ph 2 | active not recruiting | Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer |
| NCT05554380 | NCI-2022-07304 NCI-2022-07304, EAY191-S3 | Ph 2 | suspended | Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A ComboMATCH Treatment Trial |
| NCT04090398 | NCI-2019-06088 NCI-2019-06088, 052001 | Ph 2 | active not recruiting | Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones |
| 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 |
| NCT05554341 | NCI-2022-07264 NCI-2022-07264, EAY191-E4 | Ph 2 | active not recruiting | Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial |
| NCT07061977 | NCI-2025-04695 NCI-2025-04695, NRG-GY037 | Ph 3 | recruiting | Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer |
| NCT04274426 MIROVA | AGO-OVAR 2.34 2018-004207-39, 2024-516959-40-00 | Ph 2 | active not recruiting | Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer |
| NCT07195734 | NCI-2025-06920 NCI-2025-06920, NRG-HN015 | Ph 2 | recruiting | Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer |
| NCT04704934 | DS8201-A-U306 2020-004559-34 | Ph 3 | active not recruiting | Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) |
| NCT05673200 | NCI-2022-10810 NCI-2022-10810, 10546 | Ph 1 | suspended | Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer |
| NCT05256225 | NCI-2022-01540 NCI-2022-01540, NRG-GY026 | Ph 3 | suspended | Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma |
| NCT03907475 | NCI-2019-01886 NCI-2019-01886, 10292 | Ph 2 | recruiting | Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial |
| NCT06843447 | 5909-003 MK-5909-003, 2024-514674-47-00 | Ph 1, Ph 2 | recruiting | A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) |
| NCT04267848 | NCI-2020-00751 NCI-2020-00751, A081801 | Ph 3 | recruiting | Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO]) |
| NCT05564377 | NCI-2022-06842 NCI-2022-06842, EAY191 | Ph 2 | recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial |
| NCT06694454 | 10001609 001609-C | Ph 1, Ph 2 | recruiting | Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) |
| NCT06203600 | NCI-2023-11064 NCI-2023-11064, S2303 | Ph 2, Ph 3 | recruiting | Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial |
| NCT05775289 results posted | BO44178 | Ph 2 | active not recruiting | A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer |
| NCT06448754 eVOLVE-01 | D798KC00001 2023-509482-20-00 | Ph 2 | recruiting | Volrustomig Priming Regimens Exploratory Phase II Platform Study |
| NCT06445972 | 3475-06D 2023-509306-29-00, U1111-1299-8160 | Ph 1, Ph 2 | recruiting | Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06) |
| NCT05420948 | IRB22-0288 | Ph 2 | recruiting | A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer |
| NCT06161025 | DS6000-109 REJOICE-Ovarian01, ENGOT-ov77 | Ph 2, Ph 3 | recruiting | A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| NCT04245085 ABC-lung results posted | ETOP 15-19 MO40586 | Ph 2 | completed | ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma |
| NCT02689427 results posted | 2015-0488 NCI-2016-00367, 2015-0488 | Ph 2 | completed | Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer |
| NCT06043427 | GA4 | Ph 2 | recruiting | Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma |
| NCT03609047 Appalaches | EORTC 1745-ETF-BCG | Ph 2 | active not recruiting | Adjuvant Palbociclib in Elderly Patients With Breast Cancer |
| NCT06096844 | NCI-2023-08628 NCI-2023-08628, EA5221 | Ph 3 | recruiting | Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial |
| NCT06279364 | SKB264-Ⅲ-11 | Ph 3 | recruiting | A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer |
| NCT07060807 | 1022-016 U1111-1317-5490, 2025-520582-51-00 | Ph 3 | recruiting | A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) |
| NCT06385080 OrigAMI-4 | 61186372HNC2002 61186372HNC2002, 2023-508418-40-00 | Ph 1, Ph 2 | recruiting | A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck 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 |
| NCT06422143 | 2870-023 2023-510128-66-00, U1111-1301-2790 | Ph 3 | recruiting | Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] |
| NCT07071337 | SKB264-Ⅲ-13 | Ph 3 | recruiting | A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy |
| NCT07216703 | 2870-036 U1111-1319-9926, 2025-521514-26-00 | Ph 3 | recruiting | A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22) |
| NCT05498896 BARBICAN | 012418QM 2018-000977-62 | Ph 2 | active not recruiting | Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC |
| 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) |
| NCT06966700 | 2870-032 U1111-1316-7898, 2024-520190-12-00 | Ph 3 | recruiting | A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) |
| 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) |
| NCT03932409 FIERCE | OU-SCC-FIERCE | Ph 1 | active not recruiting | Frontline Immunotherapy Combined With Radiation and Chemotherapy in High Risk Endometrial Cancer |
| NCT06312137 TroFuse-019 | 2870-019 2023-508012-35-00, MK-2870-019 | Ph 3 | recruiting | A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) |
Showing 50 of 1283 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.
PACLITAXEL FDA Label Details
Indications & Usage
FDA Label (PDF)Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has b...
WARNING Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Anaphylaxis and severe hypersensi...
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Full clinical data, patents, trials, and competitive landscape for paclitaxel.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.