ALYMSYS (bevacizumab-maly) · AMNEAL PHARMS
Alymsys (bevacizumab-maly) is a vascular endothelial growth factor inhibitor used to treat several types of advanced, recurrent, and metastatic cancers, including colorectal, non-squamous non-small cell lung, renal cell, cervical, and ovarian cancers. It is also indicated for the treatment of recurrent glioblastoma in adult patients. The drug is typically administered in combination with specific chemotherapy regimens or interferon alfa, serving as either a first-line or second-line treatment depending on the malignancy. It is specifically not indicated for the adjuvant treatment of colon cancer.
How ALYMSYS Works
Alymsys functions by binding to vascular endothelial growth factor (VEGF), preventing it from interacting with its receptors, Flt-1 and KDR, on the surface of endothelial cells. In a typical biological setting, the interaction between VEGF and these receptors triggers endothelial cell proliferation and the formation of new blood vessels, known as angiogenesis. By blocking this interaction, the drug reduces microvascular growth and inhibits the progression of metastatic disease. This mechanism effectively disrupts the biological processes that support tumor vascularization.
Details
- Status
- Prescription
- First Approved
- 2022-04-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ALYMSYS Approval History
What ALYMSYS Treats
8 indicationsALYMSYS is approved for 8 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Colorectal Cancer
- Non-Small Cell Lung Cancer
- Glioblastoma
- Renal Cell Carcinoma
- Cervical Cancer
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
ALYMSYS Target & Pathway
ProTarget
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
Pathway Context
VEGF binds to VEGFR on blood vessel cells to stimulate new vessel formation
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
ALYMSYS is a lower-cost alternative to Avastin with no clinically meaningful differences. Requires prescriber approval to substitute.
ALYMSYS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ALYMSYS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ALYMSYS treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALYMSYS FDA Label Details
Indications & Usage
FDA Label (PDF)Alymsys is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use: Alymsys is not indicated for adjuvant treatment of colon cancer. Unresectable, locally advanced, recurrent or metas...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.