CLINICAL TRIALS PROFILE FOR TREANDA

505(b)(2) Clinical Trials for TREANDA

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 Combination	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	Celgene Corporation	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Combination	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	University of Wisconsin, Madison	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.

All Clinical Trials for TREANDA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00139841 ↗	Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab	Completed	Cephalon	Phase 3	2005-10-01	SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.
NCT00547534 ↗	Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma	Completed	Cephalon	Phase 2	2007-10-01	The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
NCT00547534 ↗	Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma	Completed	Millennium Pharmaceuticals, Inc.	Phase 2	2007-10-01	The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
NCT00547534 ↗	Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma	Completed	University of Rochester	Phase 2	2007-10-01	The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
NCT00758693 ↗	Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia (CLL)	Withdrawn	Cephalon	Phase 2	2008-10-01	Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.

Clinical Trial Conditions for TREANDA

Condition Name

Condition Name for TREANDA
Intervention	Trials
Chronic Lymphocytic Leukemia	21
Multiple Myeloma	12
Mantle Cell Lymphoma	10
Lymphoma	10

Condition MeSH

Condition MeSH for TREANDA
Intervention	Trials
Lymphoma	66
Leukemia, Lymphocytic, Chronic, B-Cell	37
Leukemia, Lymphoid	32
Leukemia	30

Clinical Trial Locations for TREANDA

Trials by Country

Trials by Country for TREANDA
Location	Trials
United States	556
Canada	41
Australia	25
Italy	19
Poland	11

Trials by US State

Trials by US State for TREANDA
Location	Trials
Texas	30
New York	30
California	27
Ohio	20
Missouri	19

Clinical Trial Progress for TREANDA

Clinical Trial Phase

Clinical Trial Phase for TREANDA
Clinical Trial Phase	Trials
Phase 3	13
Phase 2/Phase 3	2
Phase 2	38

Clinical Trial Status

Clinical Trial Status for TREANDA
Clinical Trial Phase	Trials
Completed	47
Active, not recruiting	16
Terminated	14

Clinical Trial Sponsors for TREANDA

Sponsor Name

Sponsor Name for TREANDA
Sponsor	Trials
National Cancer Institute (NCI)	24
Cephalon	19
M.D. Anderson Cancer Center	12

Sponsor Type

Sponsor Type for TREANDA
Sponsor	Trials
Other	103
Industry	83
NIH	24

Clinical Trials Update, Market Analysis, and Projection for Treanda (Bendamustine)

Last updated: October 28, 2025

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Introduction

Treanda (bendamustine) is an alkylating chemotherapeutic agent primarily utilized in treating hematological malignancies, notably chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Developed by Teva Pharmaceuticals, Treanda has established its position within oncologic treatment regimens due to its distinctive mechanism of inducing DNA damage and apoptosis in malignant cells. This article provides a comprehensive update on ongoing clinical trials, market dynamics, and future projections for Treanda, equipping stakeholders with strategic insights into its pharmaceutical landscape.

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Clinical Trials Overview

Recent Clinical Trial Developments

Recent years have witnessed an active pipeline of clinical assessments positioning Treanda in combination therapies, novel indications, and safety profile enhancements.

1. Combination Therapy Trials in CLL and NHL

   A prominent trial investigates Treanda combined with rituximab (a monoclonal antibody targeting CD20) in relapsed or refractory CLL patients. The trial (NCT04583977) aims to evaluate efficacy and tolerability over a 24-month period. Preliminary data suggest improved response rates with combination therapy compared to monotherapy, aligning with prior evidence supporting synergistic regimens (Liu et al., 2022).

2. Investigation in Multiple Myeloma

   A phase 2 trial (NCT04943602) examines bendamustine with lenalidomide and dexamethasone in relapsed multiple myeloma. While initially designed to explore alternative indications, early results indicate manageable safety profiles, though efficacy signals remain under review.

3. Novel Formulations and Delivery Mechanisms

   Innovations such as liposomal bendamustine formulations are under investigation (NCT04630748). These aim to improve pharmacokinetics and reduce toxicity, though data are emerging.

4. Safety and Biomarker Studies

   Ongoing surveillance studies monitor adverse effects, including secondary malignancies and infusion reactions. Importantly, genomic biomarkers predicting response are being developed to personalize therapy.

Regulatory and Approval Landscape

Treanda’s FDA approval covers CLL and indolent B-cell NHL, with supplemental indications in clinical trials. Regulatory agencies emphasize trial robustness, particularly for combination regimens, aiming to optimize disease-specific protocols.

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Market Analysis

Current Market Position

Treanda has maintained a steady niche within the chemotherapeutic market, primarily competing with rituximab, bendamustine generics, and newer targeted agents such as BTK inhibitors (e.g., ibrutinib).

The drug’s sales peaked in 2020 at roughly $350 million, driven by its established efficacy and favorable dosing schedules. However, the market faces competitive pressures from:

• Generic Bendamustine: As patent exclusivity for Treanda expires in multiple jurisdictions, generics have gained traction, reducing brand-prescribed market share.

• Targeted Therapies: BTK inhibitors and BCL-2 antagonists have gained prominence for their oral administration and reduced toxicity profiles, shaping a paradigm shift in CLL and NHL management.

Market Dynamics and Competitive Landscape

The transition to targeted agents influences Treanda’s sales; nonetheless, its role persists, especially in combinatorial regimens or in patients unsuitable for targeted therapies.

The global market for hematological malignancy drugs is projected to grow at an estimated CAGR of 6% through 2028, reaching approximately $25 billion. Treanda’s segment is expected to maintain steady, albeit modest, growth, emphasizing combination therapy segments and potential new indications.

Emerging Market Opportunities

• Developing Nations: Increasing diagnosis rates and expanding healthcare infrastructure present growth opportunities, particularly in emerging Asia-Pacific markets.

• Personalized Medicine: Biomarker-driven treatment strategies will redefine Treanda’s application scope, potentially unlocking niche markets.

• Drug Repurposing: Ongoing trials in multiple myeloma and autoimmune disorders could broaden Treanda’s therapeutic horizons.

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Future Projections

Sales Outlook (2023-2028):
Analysts forecast Treanda’s sales to stabilize around $250-$300 million annually, accounting for generic erosion and competitive therapies. The drug’s integration into combination regimens offers potential for modest growth, especially if clinical trials confirm superior efficacy.

Pipeline Impact:
If ongoing trials demonstrate significant improvements in response rates and safety profiles, regulatory approvals for expanded indications could extend Treanda’s market lifespan, fostering renewed sales momentum.

Strategic Implications:
Teva Pharmaceuticals’ emphasis on differentiating Treanda through formulation advances and companion diagnostics aligns with industry trends favoring personalized oncology. Its cautious approach toward combination therapy trials emphasizes optimizing efficacy while managing toxicity.

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Key Takeaways

• Clinical innovation continues: Multiple ongoing clinical trials evaluate Treanda in combination therapies and novel indications, which could expand its clinical utility.

• Market dynamics are shifting: The rise of targeted therapies and generics challenges Treanda’s market share, emphasizing the need for strategic positioning.

• Growth avenues include emerging markets: Developing nations and personalized medicine approaches represent promising growth pathways.

• Potential for lifecycle extension: Successful clinical trial outcomes and regulatory approvals for new indications could prolong Treanda’s market viability.

• Patient-specific applications are key: Biomarker-driven strategies will likely be central to Treanda’s future role in oncology.

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FAQs

1. What are the primary indications for Treanda?
Treanda is primarily approved for treating chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL), particularly indolent subtypes.

2. How does Treanda compare with other chemotherapies?
Treanda offers a distinctive mechanism with manageable toxicity profiles and convenient dosing, especially in combination regimens. However, targeted therapies increasingly replace traditional chemotherapies as first-line options.

3. Are there upcoming regulatory approvals for Treanda?
Pending successful clinical trial outcomes, regulatory submissions for expanded indications, such as multiple myeloma, are conceivable, though no definitive approvals are confirmed.

4. What is the outlook for Treanda’s market amid generic competition?
While patent expiration diminished exclusive sales, ongoing innovation, combination therapies, and niche indications could sustain its market relevance.

5. Could Treanda’s role in oncology grow with personalized medicine?
Yes, developments in predictive biomarkers and tailored treatment regimens could enhance Treanda’s efficacy and safety, fostering targeted use cases.

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References

1. Liu, Y., et al. (2022). Efficacy of Bendamustine and Rituximab in Combination Therapy for CLL. Journal of Hematology, 11(3), 125-134.
2. ClinicalTrials.gov. (2023). Multiple clinical trials involving Treanda (bendamustine).
3. MarketWatch. (2023). Oncology Drug Market Outlook 2023-2028.
4. Teva Pharmaceuticals. (2021). Treanda (bendamustine) prescribing information.

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In conclusion, Treanda remains a relevant entity within oncology, bolstered by ongoing innovation and clinical evaluation. Strategic navigation of competitive pressures and clinical advancements will determine its trajectory over the coming years.