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Fusilev (levoleucovorin)
Fusilev works by bypassing the enzyme dihydrofolate reductase, allowing normal cell growth and DNA synthesis.
Fusilev (levoleucovorin) is a folate analog small molecule developed by Spectrum Pharmaceuticals and currently owned by Acrotech Biopharma. It is FDA-approved since 2008 for various indications, including colorectal cancer, bone marrow suppression, and methotrexate toxicity. Fusilev works by bypassing the enzyme dihydrofolate reductase, which is inhibited by methotrexate, allowing normal cell growth and DNA synthesis. The commercial status of Fusilev is patented, with no generic manufacturers available. Key safety considerations include monitoring for bone marrow suppression and gastrointestinal toxicity.
At a glance
| Generic name | levoleucovorin |
|---|---|
| Sponsor | Acrotech Biopharma |
| Drug class | Folate Analog |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2008 |
Mechanism of action
MECHANISM OF ACTION. COBALAMIN [treatment]; FOLATE [prevention]; INTRINSIC FACTOR [facilitator] -Cobalamin is essential for the synthesis of methionine from homocysteine a reaction which also requires folate. In the absence of cobalamin ie, cobalamin deficiency, tetrahydrofolate cannot be regenerated from l-methylfolic acid, and functional folate deficiency occurs ie, methyl trap hypothesis. Gastrointestinal absorption of cobalamin depends on the presence of sufficient intrinsic factor, and lack of intrinisic factor results in cobalamin deficiency.
Approved indications
- Adjunct to Fluorouracil Treatment of Colorectal Cancer
- Bone Marrow Suppression due to Folic Acid Antagonism
- Folic acid deficiency
- Malignant tumor of stomach
- Megaloblastic anemia
- Methotrexate Toxicity
- Pyrimethamine Toxicity
- Small intestine cancer
- Sulfadiazine Toxicity
- Trimethoprim Toxicity
- Trimetrexate Toxicity
Common side effects
- Diarrhea
- Polycythemia vera
- Itching
- Transitory exanthema
- Feeling of swelling of entire body
Key clinical trials
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study (PHASE3)
- Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) (PHASE2)
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fusilev CI brief — competitive landscape report
- Fusilev updates RSS · CI watch RSS
- Acrotech Biopharma portfolio CI