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Imlygic (TALIMOGENE LAHERPAREPVEC)
Imlygic (generic name: TALIMOGENE LAHERPAREPVEC) is a Gene therapy drug developed by Amgen. It is currently FDA-approved (first approved 2015) for Local treatment of unresectable melanoma lesions.
Imlygic is a genetically modified virus that selectively infects and kills cancer cells, stimulating an anti-tumor immune response.
Imlygic (Talimogene laherparepvec) is a gene-based disrupting agent that targets melanoma cells. It is used to treat melanoma, Merkel Cell Carcinoma, and other solid tumors, including breast cancer and ductal carcinoma.
At a glance
| Generic name | TALIMOGENE LAHERPAREPVEC |
|---|---|
| Sponsor | Amgen |
| Modality | Gene therapy |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
IMLYGIC has been genetically modified to replicate within tumors and to produce the immune stimulatory protein GM-CSF. IMLYGIC causes lysis of tumors, followed by release of tumor-derived antigens, which together with virally derived GM-CSF may promote an antitumor immune response. However, the exact mechanism of action is unknown.
Approved indications
- Local treatment of unresectable melanoma lesions
Common side effects
- Fatigue
- Chills
- Pyrexia
- Influenza-like illness
- Injection site pain
- Nausea
- Vomiting
- Diarrhea
- Headache
- Myalgia
- Arthralgia
- Pain in extremity
Key clinical trials
- Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery (PHASE2)
- Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers (PHASE2)
- Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer (PHASE1,PHASE2)
- Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1 (PHASE1)
- Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection
- TVEC and Preop Radiation for Sarcoma (8 ml Dose) (PHASE1,PHASE2)
- Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin (PHASE1)
- Neoadjuvant Intralesional Injection of Talimogene Laherparepvec (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
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:
- Imlygic CI brief — competitive landscape report
- Imlygic updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Imlygic
What is Imlygic?
How does Imlygic work?
What is Imlygic used for?
Who makes Imlygic?
What is the generic name of Imlygic?
When was Imlygic approved?
What development phase is Imlygic in?
What are the side effects of Imlygic?
Related
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Local treatment of unresectable melanoma lesions
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing