INDICATION & LIMITATIONS OF USE

IMLYGIC® (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery...READ MORE

Prescribing Information Medication Guide Indication Important Safety Information References FAQ Downloads Visit Patient Site

Frequently Asked Questions

  • What results were seen in clinical trials of IMLYGIC®?

    Oncovex (GM-CSF) Pivotal Trial in Melanoma (OPTiM) was a phase 3, multicenter, open-label study of 436 stage IIIB, IIIC, and IV patients (previously treated and untreated). Patients had injectable, unresectable melanoma and were randomized 2:1 to receive IMLYGIC® or GM-CSF.1,2

    The primary endpoint in the trial was Durable Response Rate (DRR), defined as the percent of patients with a complete response (CR) or partial response (PR) maintained continuously for a minimum of 6 months.1,*

    The DRR was 16.3% in the IMLYGIC® arm (48/295) and 2.1% in the GM-CSF arm (3/141) in the overall study population. The unadjusted relative risk was 7.6 (95% CI: 2.4, 24.1); P < 0.0001.1

    There was no statistically significant difference in overall survival (OS) between the IMLYGIC® and the GM-CSF arms.

    Approximately 1 in 6 patients had a complete response or partial response for ≥ 6 months.1

    *Complete response (CR): disappearance of all evidence of tumor.3,4 Partial response (PR): 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment, as compared to baseline.3,4 Tumor responses determined using modified WHO criteria by a blinded, independent Endpoint Assessment Committee (EAC).3,4

    See more information about the durable response here.

  • What is the time to response with IMLYGIC®?

    Oncovex (GM-CSF) Pivotal Trial in Melanoma (OPTiM) was a phase 3, multicenter, open-label study of 436 stage IIIB, IIIC, and IV patients (previously treated and untreated). Patients had injectable, unresectable melanoma and were randomized 2:1 to receive IMLYGIC® or GM-CSF.1,2

    The Durable Response Rate (DRR) was 16.3% in the IMLYGIC® arm (48/295) and 2.1% in the GM-CSF arm (3/141) in the overall study population. The unadjusted relative risk was 7.6 (95% CI: 2.4, 24.1); P < 0.0001. Time to response was a key secondary endpoint.1 The median time to response was 4.1 (range: 1.2 to 16.7) months in the IMLYGIC® arm.1,3

    There was no statistically significant difference in overall survival (OS) between the IMLYGIC® and the GM-CSF arms.1

    Continue treatment with IMLYGIC® for at least 6 months—unless other treatment is required or until there are no injectable lesions to treat.1

    Read more about the trial details and results here.

  • What are the dose strengths of IMLYGIC®?

    IMLYGIC® is provided in single-use vials of 1 mL each in two different dose strengths1: 106 (1 million) plaque-forming units (PFU) per mL (light green cap)—for initial dose only, and 108 (100 million) PFU per mL (royal blue cap)—for all subsequent doses. See how to administer IMLYGIC® here.

  • How can I order IMLYGIC®?

    IMLYGIC® is shipped from select authorized specialty distributors—use the IMLYGIC® Product Ordering Guide to find a qualified distributor. You can find all the details about ordering IMLYGIC® in the storage & handling section of the site.

  • How should IMLYGIC® be stored?

    IMLYGIC® has special storage requirements that you can find in the storage & handling section of this website.

  • Are there special handling considerations for IMLYGIC®?

    Yes. Learn more about the special handling considerations for IMLYGIC® here. Please review Prescribing Information prior to handling IMLYGIC®.

  • What is Amgen Assist 360™ and how can it help?

    Amgen Assist 360™ is a comprehensive program provided by Amgen offering the tools, information, and support for Amgen oncology products that make a difference for you and your patients. Learn about Amgen Assist 360™ support here.

  • Who should I contact with a clinical inquiry?

    If you have a clinical inquiry or would like to report an adverse event related to IMLYGIC®, connect online to medical information or call 1‑800‑77‑AMGEN (1‑800‑772‑6436).

  • Who should I contact with a general inquiry that is not listed here?

    Please contact the appropriate Amgen resource using the information found here.

REFERENCES

  1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen Inc.
  2. Kaufman HL, Bines SD. OPTIM trial: a Phase III trial of an oncolytic herpes virus encoding GM-CSF for unresectable stage III or IV melanoma. Future Oncol. 2010;6:941-949.
  3. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33:2780-2788.
  4. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33(suppl Clinical Study Protocol):doi:10.1200/JCO.2014.58.3377.

IMPORTANT SAFETY INFORMATION

Contraindications
  • Do not administer IMLYGIC® to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.
  • Do not administer IMLYGIC® to pregnant patients.
Warnings and Precautions
  • Accidental exposure to IMLYGIC® may lead to transmission of IMLYGIC® and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.
  • Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
  • To prevent possible inadvertent transfer of IMLYGIC® to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.
  • Herpetic infections: Herpetic infections (including but not limited to cold sores and herpetic keratitis) and serious cases of disseminated herpetic infections have been reported in IMLYGIC-® treated patients, including fatal disseminated herpetic infection in the immunocompromised patient population. Immunocompromised patients may be at increased risk of life-threatening disseminated herpetic infection. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
  • Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the option of follow-up testing for further characterization of the infection.
  • IMLYGIC® is sensitive to acyclovir. Acyclovir or other antiviral agents may interfere with the effectiveness of IMLYGIC®. Consider the risks and benefits of IMLYGIC® treatment before administering antiviral agents to manage herpetic infection.
  • Injection Site Complications: Necrosis or ulceration of tumor tissue may occur during IMLYGIC® treatment. Cellulitis and systemic bacterial infection have been reported in clinical studies. Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
  • Impaired healing at the injection site has been reported. IMLYGIC® may increase the risk of impaired healing in patients with underlying risk factors (eg, previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.
  • Immune-Mediated events including glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with IMLYGIC®. Consider the risks and benefits of IMLYGIC® before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events.
  • Plasmacytoma at the Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC® administration in a clinical study. Consider the risks and benefits of IMLYGIC® in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
  • Obstructive Airway Disorder: Obstructive airway disorder has been reported following IMLYGIC® treatment. Use caution when injecting lesions close to major airways.
  • Hepatic Hemorrhage from Transcutaneous Intrahepatic Route of Administration: IMLYGIC is not indicated for transcutaneous intrahepatic route of administration. In clinical studies, cases of hepatic hemorrhage resulting in hospitalization and death have been reported in patients receiving transcutaneous intrahepatic IMLYGIC injections
Adverse Reactions
  • The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC®-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC® treatment, but were more frequent during the first 3 months of treatment.
  • The most common Grade 3 or higher adverse reaction was cellulitis.

Please see full Prescribing Information and Medication Guide for IMLYGIC®.

INDICATION

IMLYGIC® is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Limitations of use: IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases.

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer IMLYGIC® to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.

Do not administer IMLYGIC® to pregnant patients.

Warnings and Precautions

Accidental exposure to IMLYGIC® may lead to transmission of IMLYGIC® and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should

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