CLINICAL TRIALS PROFILE FOR FUSILEV

All Clinical Trials for FUSILEV

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03300609 ↗	5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab	Terminated	Amgen	Phase 3	2018-02-27	This randomized trial studies how well panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction work in treating patients with RAS wild type colorectal cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction may work better in treating patients with colorectal cancer.
NCT03300609 ↗	5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab	Terminated	National Cancer Institute (NCI)	Phase 3	2018-02-27	This randomized trial studies how well panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction work in treating patients with RAS wild type colorectal cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction may work better in treating patients with colorectal cancer.
NCT03222089 ↗	Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC	Withdrawn	Fujian Cancer Hospital	Phase 2	2017-07-20	A randomized phase II trial of FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer.
NCT01820091 ↗	Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®	Withdrawn	Acrotech Biopharma LLC	Phase 1	2013-04-01	To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.
NCT01820091 ↗	Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®	Withdrawn	Spectrum Pharmaceuticals, Inc	Phase 1	2013-04-01	To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.
NCT01789723 ↗	Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn	Withdrawn	Acrotech Biopharma LLC	Phase 1	2013-03-01	The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.
NCT01789723 ↗	Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn	Withdrawn	Spectrum Pharmaceuticals, Inc	Phase 1	2013-03-01	The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.

Clinical Trial Conditions for FUSILEV

Condition Name

Condition Name for FUSILEV
Intervention	Trials
Stage IV Colorectal Cancer AJCC v7	2
Stage IVA Colorectal Cancer AJCC v7	2
Stage IVB Colorectal Cancer AJCC v7	2
Gastroesophageal Junction Adenocarcinoma	1

Condition MeSH

Condition MeSH for FUSILEV
Intervention	Trials
Colorectal Neoplasms	3
Adenocarcinoma	2
Mucositis	2
Digestive System Neoplasms	1

Clinical Trial Locations for FUSILEV

Trials by Country

+

−

Trials by Country for FUSILEV
Location	Trials
United States	5
China	1

Trials by US State

+

−

Trials by US State for FUSILEV
Location	Trials
Utah	1
Minnesota	1
Georgia	1
Arizona	1
California	1

Clinical Trial Progress for FUSILEV

Clinical Trial Phase

Clinical Trial Phase for FUSILEV
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for FUSILEV
Clinical Trial Phase	Trials
Withdrawn	3
Recruiting	1
Terminated	1

Clinical Trial Sponsors for FUSILEV

Sponsor Name

Sponsor Name for FUSILEV
Sponsor	Trials
Acrotech Biopharma LLC	2
Spectrum Pharmaceuticals, Inc	2
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for FUSILEV
Sponsor	Trials
Industry	5
Other	3
NIH	2

Fusilev (Levoleucovorin): Clinical Trials, Market Analysis, and Projections

Introduction

Fusilev, also known as levoleucovorin, is a folate analog used in various clinical settings, particularly in oncology. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Indications and FDA Approval

Fusilev is FDA-approved for several specific indications:

• Rescue after high-dose methotrexate therapy in osteosarcoma and other conditions where high-dose methotrexate is used[1][4].
• Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination[1][4].
• Combination therapy with fluorouracil (5-FU) in the palliative treatment of adults with metastatic colorectal cancer[1][4].

Clinical Trials and Efficacy

Clinical trials have demonstrated the efficacy of Fusilev in its approved indications. For example:

• In the treatment of osteosarcoma, Fusilev has been shown to effectively rescue patients after high-dose methotrexate therapy, reducing toxicity and improving outcomes[1].
• In combination with 5-FU for metastatic colorectal cancer, Fusilev has been found to be as effective as racemic d,l-leucovorin in reducing gastrointestinal toxicity and other adverse reactions[4].

Market Analysis

Current Market Presence

Fusilev is marketed by Spectrum Pharmaceuticals, which has expanded its sales efforts to enhance the drug's market presence. This includes assigning additional sales staff and launching new marketing campaigns, such as the creation of a new website and professional medical education tools[5].

Sales Performance

As of 2012, Fusilev accounted for $108 million in sales for Spectrum Pharmaceuticals, representing 12% of the company's product sales for the six months ended June 30. This was a significant portion compared to other products like Zevalin, which brought in about $14.6 million during the same period[5].

Market Expansion

The marketing push by Spectrum Pharmaceuticals included increasing the sales force by around 50% without significant additional operating expenses. This strategic move aimed to leverage the oncology expertise of the sales team to boost Fusilev sales[5].

Market Projections

Overall Oncology Market

The broader oncology market, particularly for colorectal cancer treatments, is expected to grow. While Fusilev is not the only player, its specific indications and efficacy profile position it well within this growing market.

Colorectal Cancer Market

The global market for colorectal cancer treatments is anticipated to grow, driven by increasing incidence rates and the development of new therapies. By 2025, the NSCLC market, which shares some therapeutic overlaps, is projected to rise significantly, although the specific growth rate for colorectal cancer treatments may vary. However, targeted therapies and combination chemotherapies, where Fusilev plays a role, are expected to contribute to this growth[2].

Competitive Landscape

Fusilev operates in a competitive landscape where other targeted therapies and combination chemotherapies are gaining traction. For instance:

• Targeted Therapies: Drugs like Tagrisso (osimertinib) and Avastin (bevacizumab) are projected to have significant sales growth in the NSCLC market, which could influence the broader oncology market dynamics[2].
• Combination Therapies: The approval of new drugs and the expansion of existing therapies into new indications will continue to shape the market. For example, Claudin 18.2 targeted therapies, such as Vyloy (zolbetuximab), are emerging as promising treatments in gastric and other cancers, indicating a dynamic and evolving market[3].

Future Outlook

Growth Drivers

The future growth of Fusilev will be driven by several factors:

• Increasing Incidence of Cancer: The rising incidence of cancers, including colorectal cancer, will drive the demand for effective treatments.
• Expanded Marketing Efforts: Continued marketing and educational initiatives by Spectrum Pharmaceuticals will help maintain and grow Fusilev's market presence.
• Clinical Trials and New Indications: Ongoing and future clinical trials may expand Fusilev's indications, further boosting its market potential.

Challenges

Despite the growth drivers, there are challenges to consider:

• Competition from New Therapies: The emergence of new targeted therapies and combination regimens could compete with Fusilev for market share.
• Biosimilar Erosion: The introduction of biosimilars for other oncology drugs could impact the pricing and market dynamics, potentially affecting Fusilev's sales.

Key Takeaways

• Fusilev is FDA-approved for specific oncology indications, including rescue after high-dose methotrexate therapy and combination therapy with 5-FU for metastatic colorectal cancer.
• Clinical trials have demonstrated its efficacy in reducing toxicity and improving outcomes.
• The drug's market presence is being enhanced through expanded sales efforts and marketing campaigns.
• The broader oncology market is expected to grow, driven by increasing cancer incidence and the development of new therapies.
• Fusilev faces competition from emerging targeted therapies and combination regimens.

FAQs

What are the FDA-approved indications for Fusilev?

Fusilev is FDA-approved for rescue after high-dose methotrexate therapy in osteosarcoma, diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination, and use in combination chemotherapy with 5-fluorouracil in the palliative treatment of adults with advanced metastatic colorectal cancer[1][4].

How does Fusilev compare to racemic d,l-leucovorin in clinical trials?

Fusilev has been found to be as effective as racemic d,l-leucovorin in reducing gastrointestinal toxicity and other adverse reactions when used in combination with 5-FU for metastatic colorectal cancer[4].

What are the key drivers of Fusilev's market growth?

The key drivers include the increasing incidence of cancers, expanded marketing efforts by Spectrum Pharmaceuticals, and potential new indications from ongoing and future clinical trials.

How does Fusilev fit into the broader oncology market?

Fusilev operates within a growing oncology market, particularly in the segment of colorectal cancer treatments. It competes with and complements other targeted therapies and combination chemotherapies.

What challenges might Fusilev face in the market?

Fusilev may face challenges from the emergence of new targeted therapies and combination regimens, as well as the potential impact of biosimilar erosion on market dynamics.

Sources

1. Aetna: Levoleucovorin (Fusilev and Khapzory) - Medical Clinical Policy Bulletin.
2. GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
3. ResearchAndMarkets.com: Claudin 18.2 Targeted Therapy Market Forecast & Clinical Trials Insights Report 2024-2029.
4. FDA: Fusilev Label.
5. MM+M: Spectrum expands Fusilev sales presence.