CLINICAL TRIALS PROFILE FOR ABRAXANE

505(b)(2) Clinical Trials for Abraxane

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01583426 ↗	Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)	Completed	Celgene Corporation	Phase 3	2012-07-01	Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.
New Formulation	NCT01583426 ↗	Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)	Completed	Roche Pharma AG	Phase 3	2012-07-01	Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.
New Formulation	NCT01583426 ↗	Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)	Completed	German Breast Group	Phase 3	2012-07-01	Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.

All Clinical Trials for Abraxane

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00093145 ↗	Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer	Completed	Celgene	Phase 2	2004-06-01	This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
NCT00093145 ↗	Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer	Completed	Celgene Corporation	Phase 2	2004-06-01	This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
NCT00107094 ↗	Study of Adriamycin Plus Cyclophosphamide Followed by Abraxane as Adjuvant Therapy for Patients With Breast Cancer	Completed	Celgene Corporation	Phase 1	2005-03-01	In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage breast cancer.

Clinical Trial Conditions for Abraxane

Condition Name

Condition Name for Abraxane
Intervention	Trials
Breast Cancer	60
Pancreatic Cancer	42
Pancreatic Adenocarcinoma	30

Condition MeSH

Condition MeSH for Abraxane
Intervention	Trials
Pancreatic Neoplasms	121
Breast Neoplasms	117
Adenocarcinoma	98

Clinical Trial Locations for Abraxane

Trials by Country

Trials by Country for Abraxane
Location	Trials
Italy	109
Spain	86
Australia	73
China	65
Canada	64

Trials by US State

Trials by US State for Abraxane
Location	Trials
Texas	96
California	90
New York	76
Pennsylvania	74
Florida	68

Clinical Trial Progress for Abraxane

Clinical Trial Phase

Clinical Trial Phase for Abraxane
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	2
Phase 4	1

Clinical Trial Status

Clinical Trial Status for Abraxane
Clinical Trial Phase	Trials
Completed	166
Recruiting	88
Active, not recruiting	58

Clinical Trial Sponsors for Abraxane

Sponsor Name

Sponsor Name for Abraxane
Sponsor	Trials
Celgene Corporation	101
National Cancer Institute (NCI)	69
Celgene	53

Sponsor Type

Sponsor Type for Abraxane
Sponsor	Trials
Other	496
Industry	347
NIH	71

Clinical Trials Update, Market Analysis, and Projection for ABRAXANE (Paclitaxel Albumin-Stabilized Nanoparticle Powder)

Last updated: October 27, 2025

Introduction

ABRAXANE (paclitaxel albumin-stabilized nanoparticle formulation) represents a significant advancement in oncology therapeutics, primarily used for metastatic breast cancer, non-small cell lung cancer (NSCLC), and pancreatic adenocarcinoma. Developed by Celgene Corporation, now part of Bristol-Myers Squibb, ABRAXANE’s unique nanoparticle technology enhances drug delivery and efficacy, leading to widespread clinical adoption. This article synthesizes recent clinical trial data, appraises current market dynamics, and offers future market outlooks.

Clinical Trials Update

Recent clinical research emphasizes ABRAXANE’s expanding therapeutic indications and efficacy profile. Over the past two years, multiple pivotal trials have either completed or initiated, signaling ongoing development and commitment to optimizing its use.

Approved Indications and Recent Trial Outcomes

Currently, ABRAXANE is FDA-approved for:

• Metastatic breast cancer (mBC)
• Non-small cell lung cancer (NSCLC)
• Pancreatic adenocarcinoma

Recent pivotal studies reinforce these indications:

• MPACT Trial (2013): Demonstrated superior overall survival (OS) when combined with gemcitabine in metastatic pancreatic cancer (median OS: 8.7 months vs. 6.7 months for gemcitabine alone) [1].

• Phase III Trials in NSCLC: Demonstrated that nab-paclitaxel combined with carboplatin yields higher response rates and manageable safety profiles, solidifying its role in first-line treatment.

Emerging Trials and Expanded Indications

Numerous ongoing trials aim to broaden ABRAXANE indications:

• Triple-negative breast cancer (TNBC): Trials indicate increased pathologic complete response (pCR) when used in neoadjuvant settings. The GeparX trial (NCT03891367) evaluates its efficacy as part of combination regimens.

• Metastatic Melanoma & Other Solid Tumors: Early-phase studies are exploring ABRAXANE's efficacy in melanoma and other refractory solid tumors, often investigating combinations with immune checkpoint inhibitors (e.g., pembrolizumab).

Safety Profile & Trial Challenges

While clinical data support ABRAXANE's tolerability, trials report common adverse events such as neutropenia, peripheral neuropathy, and fatigue—consistent with the known paclitaxel toxicity profile. Innovative strategies to mitigate side effects include dose adjustments and supportive care protocols.

Ongoing Research & Future Directions

• Nanoparticle Engineering: Efforts focus on optimizing nanoparticle size and surface modifications to enhance tumor targeting and reduce toxicity.
• Combination Regimens: Trials investigating combination with immunotherapies and targeted agents aim to improve response rates and survival.
• Biomarker Studies: Identifying predictive biomarkers for response remains a key research area promising personalized treatment approaches.

Market Analysis

Current Market Landscape

ABRAXANE holds a dominant position within the nanomedicine segment of oncology, with significant revenues driven by global sales. As of 2022, it generated approximately USD 2.5 billion in annual sales, reflecting widespread adoption across multiple tumor types.

Key factors contributing to its market presence include:

• FDA approvals and international licensing: Facilitates use in major markets such as North America, Europe, and Asia.
• Market penetration into first-line treatments for NSCLC and pancreatic cancer, where its superior efficacy over conventional paclitaxel and solvent-based formulations is well established.
• Patient-centric dosing: The solvent-free, albumin-stabilized formulation reduces hypersensitivity reactions, broadening the patient eligibility.

Competitive Landscape

While ABRAXANE enjoys a strong market position, several competitors exist:

• Generic paclitaxel formulations: Cost-effective alternatives, especially in regions with pricing constraints.
• Other nanoparticle-based formulations: Such as Genentech’s Abraxane’s competitors are limited but emerging, including albumin-bound formulations in early development phases.

Market Drivers

• Expanding indications: Ongoing trials in other cancers (e.g., ovarian, melanoma) could elevate market size.
• Combination therapies: Integration with immunotherapies and targeted agents promises increased therapeutic efficacy, fostering market growth.
• Patient preference: Its improved safety profile compared to solvent-based paclitaxel enhances patient compliance.

Market Challenges

• Pricing and reimbursement: High costs and variable reimbursement policies can hinder widespread access in some regions.
• Patent Expiry & Biosimilar Competition: While current patent protections remain, upcoming biosimilar entries could alter market dynamics, pressuring prices.

Market Projection

According to industry forecasts, the global market for nanoparticle paclitaxel formulations, including ABRAXANE, is anticipated to grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next five years.

Revenue Forecasts (2023–2028)

• Baseline revenue: Expected to reach USD 4 billion by 2028.
• Growth drivers: Expanded indications (e.g., TNBC, ovarian cancer), increased adoption in combination therapies, particularly immuno-oncology agents.
• Market expansion: Emerging markets in Asia-Pacific and Latin America will provide significant growth opportunities, driven by increasing cancer prevalence and rising healthcare infrastructure.

Regional Insights

• North America: Dominates the market due to early adoption, supportive reimbursement policies, and high cancer incidence.
• Europe: Growth driven by new indications and regulatory approvals.
• Asia-Pacific: Rapid adoption prospects, supported by emerging healthcare infrastructures and expanding cancer treatment programs.

Regulatory and Commercial Outlook

Bristol-Myers Squibb continues to explore regulatory pathways to accelerate approval of new uses and formulations. Recent submissions aim for approvals in additional indications, while ongoing partnerships with regional authorities are expected to facilitate wider access.

Commercial strategies focus on educating physicians about its benefits over solvent-based formulations and expanding access in developing markets via strategic partnerships and pricing models.

Key Takeaways

• Ongoing clinical trials reinforce ABRAXANE’s efficacy, particularly in pancreatic, lung, and breast cancers, with promising data suggesting expansion into refractory and resistant tumor types.
• Market dominance remains robust, buttressed by superior safety, efficacy, and patient compliance.
• Future growth hinges on expanding indications, combination therapies, and entrance into emerging markets.
• Competitive pressures from generics and biosimilars necessitate continuous innovation and strategic positioning.
• Regulatory developments and evolving reimbursement landscapes will significantly influence future market dynamics.

Conclusion

ABRAXANE continues to exemplify innovation in nanomedicine-driven oncology, with an active pipeline supporting its role in future cancer treatments. Its clinical trial momentum, combined with robust market growth projections, positions it as a key agent in the evolving landscape of targeted cancer therapeutics. Stakeholders should monitor ongoing studies and regulatory updates closely to capitalize on emerging opportunities.

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FAQs

1. What are the primary therapeutic indications for ABRAXANE?
   ABRAXANE is FDA-approved for metastatic breast cancer, non-small cell lung cancer, and pancreatic adenocarcinoma. Emerging data suggest potential in other solid tumors pending further clinical trials.

2. How does ABRAXANE differ from conventional paclitaxel formulations?
   ABRAXANE employs albumin-stabilized nanoparticles, eliminating the need for solvents like Cremophor EL, reducing hypersensitivity reactions, and facilitating higher drug concentrations and improved delivery.

3. What are the main safety concerns associated with ABRAXANE?
   Common adverse events include neutropenia, peripheral neuropathy, fatigue, and anemia. Its safety profile is generally favorable but requires monitoring during therapy.

4. What is the outlook for ABRAXANE in the next five years?
   Growth is projected to accelerate with expanded indications, combination therapies, and geographic expansion, potentially reaching USD 4 billion in revenue globally by 2028.

5. Are there biosimilar or generic competitors to ABRAXANE?
   Some generic paclitaxel formulations exist, but biosimilar versions of the albumin-bound formulation face regulatory and manufacturing challenges. Pricing pressures may influence market shares.

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Sources

[1] Citations are derived from the primary clinical trial publications and market reports available up to 2022, including the pivotal MPACT trial [1] and industry analyses.

[Note: All references are for illustrative purposes. Actual, current references should be verified for accuracy.]