Fusilev

(Levoleucovorin)

Phase 3Small molecule

DDurata Therapeutics International BV (an Affiliate of Actavis, Inc.)

Fusilev is one of 252 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

251

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaRecruiting

Esophageal CarcinomaActive, not recruiting

Esophageal CancerActive, not recruiting

LeukemiaActive, not recruiting

Esophageal AdenocarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Acute Lymphoblastic LeukemiaActive, not recruiting

Acute Leukemia of Ambiguous LineageRecruiting

Esophageal Squamous Cell CarcinomaPreclinical

Recruiting

Esophageal CarcinomaPhase 3

Active, not recruiting

Esophageal CancerPhase 1/Phase 2

Active, not recruiting

LeukemiaPhase 2

Active, not recruiting

Esophageal AdenocarcinomaPhase 1/Phase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 3

Active, not recruiting

Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Acute Leukemia of Ambiguous LineagePhase 2

Recruiting

Competition

Competitive Landscape

698 competitors in Metastatic Colorectal Cancer

#DrugCompanyPhaseTrials

Braftovi

Pfizer

Phase 3

11 2

Folinic Acid

Roche

Phase 3

17 3

Ofev

Boehringer Ingelheim

Phase 3

3 4

Fusilev

DDurata Therapeutics International BV (an Affiliate of Actavis, Inc.)

Phase 3

1 5

Legalon

BBukwang Pharmaceutical

Phase 3

1 6

Cecon

MMcGuff Pharmaceuticals, Inc.

Phase 3

1 7

PF-08634404

Pfizer

Phase 3

—8

Anlotinib Hydrochloride

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Phase 3

1 9

Donafenib

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase 3

1 10

Mfolfoxiri

DDominik Paul Modest

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Pd-1antibody

NCT05945823

Phase 3Active, not recruiting

Esophageal Carcinoma

NCT04210115

Q3 2027

Phase 3Active, not recruiting

Acute Lymphoblastic Leukemia

NCT03007147

Q4 2028

Phase 2Recruiting

Acute Leukemia of Ambiguous Lineage

NCT06317662

Q3 2029

Phase 3Recruiting

Metastatic Colorectal Cancer

NCT05253651

Phase 1/2Recruiting

Esophageal Adenocarcinoma

NCT06469944

Clinical

Trials by Indication[1]

Esophageal Carcinoma2 trials

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT04949256·864 enrolled

Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT04210115·703 enrolled

Acute Lymphoblastic Leukemia1 trial

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT03007147·475 enrolled

PD-1antibody1 trial

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

Active, not recruiting· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT05945823·53 enrolled

Metastatic Colorectal Cancer1 trial

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT05253651·400 enrolled

Esophageal Adenocarcinoma1 trial

Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT06469944·160 enrolled

4 more indications

Liver Metastases1 trial

Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab

Completed·—·Phase 2·NCT03698461·20 enrolled

First Line Therapy1 trial

Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC

Withdrawn·FFujian Cancer Hospital·Phase 2·NCT03222089

Acute Leukemia of Ambiguous Lineage1 trial

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06317662·153 enrolled

Esophageal Squamous Cell Carcinoma1 trial

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06780111·298 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 7, 2008

FUSILEV

NDA NDA020140

Sep 29, 2016

LEVOLEUCOVORIN CALCIUM

NDA NDA208723

Oct 19, 2018

KHAPZORY

NDA NDA211226

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Levoleucovorin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Levoleucovorin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Levoleucovorin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211226). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Fusilev. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Durata Therapeutics International BV (an Affiliate of Actavis, Inc.) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDurata Therapeutics International BV (an Affiliate of Actavis, Inc.)

Patent Landscape[5]

Patent Cliff

Mar 25, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11541012Mar 25, 2039

Fusilev

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q4 2028

Q3 2029

Trials by Indication[1]

Esophageal Carcinoma2 trials

Acute Lymphoblastic Leukemia1 trial

PD-1antibody1 trial

Metastatic Colorectal Cancer1 trial

Esophageal Adenocarcinoma1 trial

Liver Metastases1 trial

First Line Therapy1 trial

Acute Leukemia of Ambiguous Lineage1 trial

Esophageal Squamous Cell Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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