CLINICAL TRIALS PROFILE FOR BELRAPZO

All Clinical Trials for belrapzo

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01286272 ↗	Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2011-04-08	This randomized phase II trial studies how well ofatumumab and bendamustine hydrochloride with or without bortezomib works in treating patients with untreated follicular non-Hodgkin lymphoma. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. It is not yet known whether ofatumumab and bendamustine hydrochloride are more effective with bortezomib in treating patients with follicular non-Hodgkin lymphoma.
NCT01886872 ↗	Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2013-12-09	This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.
NCT02153580 ↗	Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2014-09-24	This phase I trial studies the side effects and best dose of cellular immunotherapy following chemotherapy in treating patients with non-Hodgkin lymphomas, chronic lymphocytic leukemia, or B-cell prolymphocytic leukemia that has come back. Placing a modified gene into white blood cells may help the body build an immune response to kill cancer cells.
NCT02153580 ↗	Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia	Active, not recruiting	City of Hope Medical Center	Phase 1	2014-09-24	This phase I trial studies the side effects and best dose of cellular immunotherapy following chemotherapy in treating patients with non-Hodgkin lymphomas, chronic lymphocytic leukemia, or B-cell prolymphocytic leukemia that has come back. Placing a modified gene into white blood cells may help the body build an immune response to kill cancer cells.
NCT03269669 ↗	Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2017-08-10	This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.

Clinical Trial Conditions for belrapzo

Condition Name

Condition Name for belrapzo
Intervention	Trials
Grade 3a Follicular Lymphoma	2
Recurrent Follicular Lymphoma	2
Ann Arbor Stage III Grade 2 Follicular Lymphoma	1
Stage III Chronic Lymphocytic Leukemia	1

Condition MeSH

Condition MeSH for belrapzo
Intervention	Trials
Lymphoma	3
Lymphoma, Follicular	3
Leukemia, Lymphoid	2
Leukemia, Lymphocytic, Chronic, B-Cell	2

Clinical Trial Locations for belrapzo

Trials by Country

Trials by Country for belrapzo
Location	Trials
United States	115
Canada	6

Trials by US State

Trials by US State for belrapzo
Location	Trials
California	4
Connecticut	3
West Virginia	3
South Carolina	3
Pennsylvania	3

Clinical Trial Progress for belrapzo

Clinical Trial Phase

Clinical Trial Phase for belrapzo
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for belrapzo
Clinical Trial Phase	Trials
Active, not recruiting	3
Recruiting	1

Clinical Trial Sponsors for belrapzo

Sponsor Name

Sponsor Name for belrapzo
Sponsor	Trials
National Cancer Institute (NCI)	4
City of Hope Medical Center	1

Sponsor Type

Sponsor Type for belrapzo
Sponsor	Trials
NIH	4
Other	1

Belrapzo Market Analysis and Financial Projection

BELRAPZO: Clinical Trials, Market Analysis, and Projections

Introduction

BELRAPZO, a bendamustine hydrochloride injection, is a crucial treatment option for patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Here, we delve into the current clinical trials, market analysis, and future projections for BELRAPZO.

Clinical Trials Update

Ongoing Studies

BELRAPZO is not the primary focus of new clinical trials, but its active ingredient, bendamustine, continues to be studied in various contexts. For instance, the National Cancer Institute (NCI) and other institutions are conducting Phase 1 and Phase 3 trials involving bendamustine in combination with other therapies[5].

Recent Developments

While BELRAPZO itself is not in new clinical trials, Eagle Pharmaceuticals, the company marketing BELRAPZO, is involved in several other significant clinical studies. One notable example is the Phase 2 study of CAL02, a novel anti-virulence agent for treating severe community-acquired bacterial pneumonia. This study is ongoing and aims to enroll approximately 276 patients across over 20 countries[3].

Market Analysis

Current Market Position

BELRAPZO, along with its sister product BENDEKA, holds a significant market share in the bendamustine market. As of February 2023, these two products maintained an 88% share of the U.S. bendamustine market, despite the entry of generic competitors[2].

Revenue and Growth

The bendamustine franchise, which includes BELRAPZO, BENDEKA, and TREAKISYM (marketed in Japan), saw revenue growth in 2022 compared to 2021. The company anticipates that the gross profits from these products in 2023 will be approximately 75% of the 2022 gross profit, reflecting a strong market presence[2].

Competitive Landscape

The bendamustine market has seen increased competition with the approval of generic versions. However, BELRAPZO and BENDEKA remain differentiated products due to their patent protection until 2028. This differentiation, combined with the expiration of a 10% royalty to an early development partner in the fourth quarter of 2022, has enhanced the margin on bendamustine sales[2].

Market Projections

Future Outlook

Despite the competitive landscape, Eagle Pharmaceuticals remains optimistic about the future of its bendamustine franchise. The company has taken steps to defend its market share, including reaching settlement agreements with generic manufacturers like Dr. Reddy's Laboratories and Accord Healthcare[2].

Financial Projections

The elimination of the royalty on the first $85 million of profit from PEMFEXY, another product by Eagle Pharmaceuticals, and the reduced royalty thereafter, has positively impacted the company's financial outlook. This, combined with the strong performance of the bendamustine franchise, suggests continued profitability in 2023[2].

Key Factors Influencing Market Projections

Patent Protection

BELRAPZO is protected by sixteen US patents and sixty-four patent family members in thirty countries. This extensive patent protection helps maintain its market position against generic competitors[5].

Regulatory Environment

The regulatory environment, including the approval of generic versions and the company's legal actions to defend its patents, plays a crucial role in shaping the market. Eagle Pharmaceuticals' successful defense of its bendamustine franchise against Paragraph IV challenges is a significant factor in its market projections[5].

Clinical and Commercial Strategies

Eagle Pharmaceuticals' strategic acquisitions, such as the equity stake in Enalare Therapeutics, and its focus on organic growth, are expected to contribute to the company's overall performance and the success of its bendamustine franchise[2].

Conclusion

BELRAPZO remains a vital component of Eagle Pharmaceuticals' portfolio, particularly in the treatment of CLL and NHL. Despite the entry of generic competitors, the product's strong market position, patent protection, and the company's strategic initiatives ensure its continued relevance and profitability.

Key Takeaways

• Clinical Trials: While BELRAPZO is not in new clinical trials, its active ingredient is being studied in various contexts.
• Market Position: BELRAPZO and BENDEKA hold a significant market share in the bendamustine market.
• Revenue and Growth: The bendamustine franchise saw revenue growth in 2022 and is expected to maintain strong gross profits in 2023.
• Competitive Landscape: The market is competitive, but patent protection and strategic actions help maintain market share.
• Future Outlook: The company remains optimistic about the future of its bendamustine franchise.

FAQs

What is BELRAPZO used for?

BELRAPZO is used for the treatment of patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen[4].

What is the recommended dosage for BELRAPZO?

For CLL, the recommended dosage is 100 mg/m² administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles. For NHL, it is 120 mg/m² administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles[1].

What are the potential side effects of BELRAPZO?

BELRAPZO can cause serious side effects, including fatal and serious skin reactions, impaired male fertility, and significant hematologic and non-hematologic toxicities[1][4].

Is BELRAPZO protected by patents?

Yes, BELRAPZO is protected by sixteen US patents and sixty-four patent family members in thirty countries[5].

How does the competitive landscape affect BELRAPZO?

Despite the entry of generic competitors, BELRAPZO and BENDEKA maintain a strong market share due to their patent protection and the company's strategic actions to defend the franchise[2].

Sources

1. FDA Label for BELRAPZO: Access Data FDA, "BELRAPZO (bendamustine hydrochloride) injection, for intravenous use".
2. Eagle Pharmaceuticals Annual Report: Eagle Pharmaceuticals, "Annual Report 2022".
3. Biospace Update on CAL02: Biospace, "Eagle Pharmaceuticals Provides Business Update and Reiterates 2023 Guidance".
4. Official BELRAPZO Website: BELRAPZO, "BELRAPZO (Bendamustine Hydrochloride Injection) | Official HCP Website".
5. DrugPatentWatch Profile for BELRAPZO: DrugPatentWatch, "BELRAPZO Drug Patent Profile".