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Fusilev (Levofolinic acid)
Fusilev (Levofolinic acid) is a folate analog small molecule developed by Spectrum Pharmaceuticals. It is used as an adjunct to fluorouracil treatment of colorectal cancer and to treat various conditions including bone marrow suppression, folic acid deficiency, and methotrexate toxicity. Fusilev is FDA-approved and has been on the market since 2008. The commercial status of Fusilev is patented, and it is used to counteract the toxic effects of certain chemotherapy agents. Key safety considerations include its potential to exacerbate certain conditions.
At a glance
| Generic name | Levofolinic acid |
|---|---|
| Sponsor | Spectrum Pharms |
| Drug class | Folate Analog |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2008 |
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
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
- Spectrum Pharms portfolio CI