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

In unresectable melanoma recurrent after initial surgery

Inject the lesion. Trigger an immune response. That's the precision of IMLYGIC®1,*

*IMLYGIC® is the first and only FDA-approved2 oncolytic viral therapy designed to replicate in cancer cells, leading to oncolysis, whereby the release of tumor-derived antigens, virally derived GM-CSF, and replicated IMLYGIC® may promote an antitumor immune response.1 The exact mechanism of action is unknown.1

See how IMLYGIC® is different

In OPTiM, IMLYGIC® delivered a Durable Response—

shown continuously for 6 months or more1,3

~1 IN 6 PATIENTS HAD A CR AND/OR PR FOR ≥ 6 MONTHS1,5

See 3 examples of actual results
  • OncovexGM-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.1,4,5
  • 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. The median time to response was 4.1 (range: 1.2 to 16.7) months in the IMLYGIC® arm.1,5
  • There was no statistically significant difference in Overall Survival (OS) between the IMLYGIC® and the GM-CSF arms.1

DRR: defined as the percent of patients with a CR or PR maintained continuously for a minimum of 6 months1; Complete response (CR): disappearance of all evidence of tumor5,6; 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 baseline5,6; Tumor responses were determined using modified WHO criteria by a blinded, independent Endpoint Assessment Committee (EAC)5,6; GM-CSF = granulocyte-macrophage colony-stimulating factor.

*Ongoing response refers to the primary endpoint of Durable Response Rate, defined as the percent of patients with a Complete Response or Partial Response maintained continuously for a minimum of 6 months.

Patients with stage IIIB, IIIC, or IV melanoma that was not considered to be surgically resectable experienced ongoing* and clinically meaningful responses with IMLYGIC®.1,5,7

Patient with Complete Response3,†
Photographs of a patient with a Complete Response
Before: Cycle 1
Photographs of a patient with a Complete Response
After: Cycle 13
Patient with Partial Response3
Photographs of a patient with a Partial Response
Before: Cycle 1
Photographs of a patient with a Partial Response
After: Cycle 10

*Ongoing response refers to the primary endpoint of Durable Response Rate, defined as the percent of patients with a Complete Response or Partial Response maintained continuously for a minimum of 6 months.

†CR confirmed by biopsy.6
Individual results may vary.
Examples shown are for two patients in the phase 3 study.

Review the efficacy of IMLYGIC®

IMLYGIC® has a proven safety profile1,5

Evaluate the safety of IMLYGIC®

IMLYGIC® starts with injection directly into the lesion1

Administer IMLYGIC® by intralesional injection into cutaneous, subcutaneous, and nodal lesions that are visible, palpable, or detectable by ultrasound guidance; do not administer intravenously.1

Read about dosing and administration

IMLYGIC® has special storage and handling considerations1

Information on storage requirements of IMLYGIC®, as well as details on procurement, ordering, and safe handling. Please review the Prescribing Information prior to handling IMLYGIC®.

Learn more about IMLYGIC® storage and handling details

REFERENCES

  1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex LLC., a subsidiary of Amgen Inc.
  2. FDA approves first oncolytic virus therapy: Imlygic for melanoma. Oncology Times. 2015;37:36. doi:10.1097/01.COT.0000475724.97729.9e.
  3. Data on file. Amgen; 2015.
  4. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33:2780-2788.
  5. Kaufman HL, Bines SD. OPTiM trial: a Phase Ill trial of an oncolytic herpes virus encoding GM-CSF for unresectable stage Ill or IV melanoma. Future Oncol. 2010;6:941-949.
  6. 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.
  7. US Food and Drug Administration. Summary basis for regulatory action. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/Approved/Products/UCM473103.pdf. Published October 27, 2015. Accessed March 24, 2017.

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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