FDA recently approved the first oncolytic virus therapy: talimogene laherparepvec (Imlygic—BioVex/Amgen), a modified live herpes simplex virus type 1 oncolytic virus therapy, for the treatment of recurrent melanoma.“Imlygic is a unique melanoma treatment in that it has to be injected directly into the melanoma lesions themselves. Even though patients won’t have all of their lesions injected, even noninjected lesions can respond to the drug,” said Christine Walko, PharmD, BCOP, personalized medicine specialist at the Moffitt Cancer Center in Tampa, FL.“Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, said in an FDA news release. “This approval provides patients and health care providers with a novel treatment for melanoma.”Safety and efficacy in clinical trialsResearchers conducted an open-label, randomized clinical trial to evaluate the safety of talimogene laherparepvec in 419 patients with stage IIIB, IIIC, and IV melanoma that was not surgically resectable. Patients in the trial received at least one dose of either talimogene laherparepvec (n=292) via intralesional injection or granulocyte-macrophage colony-stimulating factor (GM-CSF) subcutaneously (n=127). The median duration of exposure to talimogene laherparepvec was 23 weeks, and 26 patients received the drug for at least 12 months. Common adverse effects included chills, fever, fatigue, nausea, influenza-like symptoms, and injection-site pain, and the most common grade 3 or higher adverse reaction was cellulitis.To evaluate the efficacy of talimogene laherparepvec, investigators conducted another open-label, randomized clinical trial of 436 patients with stage IIIB, IIIC, and IV melanoma that was not surgically resectable (43% women; mean age 63 years; 98% white). Patients were treated for at least 6 months unless no injectable lesions or intolerable adverse effects developed (talimogene laherparepvec group: n=295; GM-CSF group: n=141). The primary efficacy endpoint was durable response rate (DRR), defined as the percentage of patients who maintained complete response or partial response for at least 6 months. The DRR was 16.3% in the talimogene laherparepvec group compared with 2.1% in the GM-CSF group (unadjusted relative risk, 7.6 [95% CI 2.4–24.1]; P <0.0001). There was no statistically significant difference in overall survival between the two treatment groups (22.9 months in the talimogene laherparepvec group versus 19.0 months in the GM-CSF group; P=0.116).Clinical pearlsTalimogene laherparepvec is not for use in pregnant women or immunocompromised patients because of the risk of herpes virus infection. Immunocompromised or pregnant health care providers should not prepare or administer the drug or come in contact with injection sites, dressings, or bodily fluids from treated patients. The dosing of talimogene laherparepvec is based on lesion size but should not exceed a total of 4 mL per treatment session regardless if all lesions are injected. Hazardous waste disposal and handling procedures are necessary.Talimogene laherparepvec (Imlygic)Manufacturer: BioVex/AmgenDrug class: Antineoplastic agent (oncolytic virus)Indication: Treatment of unresectable lesions (subcutaneous and nodal) in patients with recurrent melanomaDosage: Administer via intralesional injection into cutaneous, subcutaneous, and/or nodal melanoma lesions. Dosing is based on lesion size (see prescribing information) with a starting dose of up to 4 mL (at a concentration of 106 [1 million] plaque-forming units [PFU] per mL) and subsequent doses (3 weeks after initial treatment and then 2 weeks after previous treatment) up to 4 mL at a concentration of 108 [100 million] PFU per mL. Not all lesions may be injected if the total injection volume required is more than 4 mL during a treatment session. Treatment duration is at least 6 months.Of note: Two different strengths are available: 106 PFU per mL (light green cap) and 108 PFU per mL (royal blue cap) for initial and subsequent doses, respectively. Provide the FDA-approved medication guide to patients receiving talimogene laherparepvec.Patient counselingWomen of childbearing potential should use effective contraception and should not breastfeed during treatment with talimogene laherparepvec. Counsel patients to avoid touching injection sites or injection site dressings (wear gloves when changing dressings) so talimogene laherparepvec is not transferred to any other areas of the body or other people. Also alert patients to avoid exposing others to their body fluids (such as by using condoms or avoiding contact if open sores) and to avoid close contact with pregnant women or those with weakened immune systems during their talimogene laherparepvec therapy. FDA recently approved the first oncolytic virus therapy: talimogene laherparepvec (Imlygic—BioVex/Amgen), a modified live herpes simplex virus type 1 oncolytic virus therapy, for the treatment of recurrent melanoma. “Imlygic is a unique melanoma treatment in that it has to be injected directly into the melanoma lesions themselves. Even though patients won’t have all of their lesions injected, even noninjected lesions can respond to the drug,” said Christine Walko, PharmD, BCOP, personalized medicine specialist at the Moffitt Cancer Center in Tampa, FL. “Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, said in an FDA news release. “This approval provides patients and health care providers with a novel treatment for melanoma.” Safety and efficacy in clinical trialsResearchers conducted an open-label, randomized clinical trial to evaluate the safety of talimogene laherparepvec in 419 patients with stage IIIB, IIIC, and IV melanoma that was not surgically resectable. Patients in the trial received at least one dose of either talimogene laherparepvec (n=292) via intralesional injection or granulocyte-macrophage colony-stimulating factor (GM-CSF) subcutaneously (n=127). The median duration of exposure to talimogene laherparepvec was 23 weeks, and 26 patients received the drug for at least 12 months. Common adverse effects included chills, fever, fatigue, nausea, influenza-like symptoms, and injection-site pain, and the most common grade 3 or higher adverse reaction was cellulitis.To evaluate the efficacy of talimogene laherparepvec, investigators conducted another open-label, randomized clinical trial of 436 patients with stage IIIB, IIIC, and IV melanoma that was not surgically resectable (43% women; mean age 63 years; 98% white). Patients were treated for at least 6 months unless no injectable lesions or intolerable adverse effects developed (talimogene laherparepvec group: n=295; GM-CSF group: n=141). The primary efficacy endpoint was durable response rate (DRR), defined as the percentage of patients who maintained complete response or partial response for at least 6 months. The DRR was 16.3% in the talimogene laherparepvec group compared with 2.1% in the GM-CSF group (unadjusted relative risk, 7.6 [95% CI 2.4–24.1]; P <0.0001). There was no statistically significant difference in overall survival between the two treatment groups (22.9 months in the talimogene laherparepvec group versus 19.0 months in the GM-CSF group; P=0.116). Researchers conducted an open-label, randomized clinical trial to evaluate the safety of talimogene laherparepvec in 419 patients with stage IIIB, IIIC, and IV melanoma that was not surgically resectable. Patients in the trial received at least one dose of either talimogene laherparepvec (n=292) via intralesional injection or granulocyte-macrophage colony-stimulating factor (GM-CSF) subcutaneously (n=127). The median duration of exposure to talimogene laherparepvec was 23 weeks, and 26 patients received the drug for at least 12 months. Common adverse effects included chills, fever, fatigue, nausea, influenza-like symptoms, and injection-site pain, and the most common grade 3 or higher adverse reaction was cellulitis. To evaluate the efficacy of talimogene laherparepvec, investigators conducted another open-label, randomized clinical trial of 436 patients with stage IIIB, IIIC, and IV melanoma that was not surgically resectable (43% women; mean age 63 years; 98% white). Patients were treated for at least 6 months unless no injectable lesions or intolerable adverse effects developed (talimogene laherparepvec group: n=295; GM-CSF group: n=141). The primary efficacy endpoint was durable response rate (DRR), defined as the percentage of patients who maintained complete response or partial response for at least 6 months. The DRR was 16.3% in the talimogene laherparepvec group compared with 2.1% in the GM-CSF group (unadjusted relative risk, 7.6 [95% CI 2.4–24.1]; P <0.0001). There was no statistically significant difference in overall survival between the two treatment groups (22.9 months in the talimogene laherparepvec group versus 19.0 months in the GM-CSF group; P=0.116). Clinical pearlsTalimogene laherparepvec is not for use in pregnant women or immunocompromised patients because of the risk of herpes virus infection. Immunocompromised or pregnant health care providers should not prepare or administer the drug or come in contact with injection sites, dressings, or bodily fluids from treated patients. The dosing of talimogene laherparepvec is based on lesion size but should not exceed a total of 4 mL per treatment session regardless if all lesions are injected. Hazardous waste disposal and handling procedures are necessary.Talimogene laherparepvec (Imlygic)Manufacturer: BioVex/AmgenDrug class: Antineoplastic agent (oncolytic virus)Indication: Treatment of unresectable lesions (subcutaneous and nodal) in patients with recurrent melanomaDosage: Administer via intralesional injection into cutaneous, subcutaneous, and/or nodal melanoma lesions. Dosing is based on lesion size (see prescribing information) with a starting dose of up to 4 mL (at a concentration of 106 [1 million] plaque-forming units [PFU] per mL) and subsequent doses (3 weeks after initial treatment and then 2 weeks after previous treatment) up to 4 mL at a concentration of 108 [100 million] PFU per mL. Not all lesions may be injected if the total injection volume required is more than 4 mL during a treatment session. Treatment duration is at least 6 months.Of note: Two different strengths are available: 106 PFU per mL (light green cap) and 108 PFU per mL (royal blue cap) for initial and subsequent doses, respectively. Provide the FDA-approved medication guide to patients receiving talimogene laherparepvec.Patient counselingWomen of childbearing potential should use effective contraception and should not breastfeed during treatment with talimogene laherparepvec. Counsel patients to avoid touching injection sites or injection site dressings (wear gloves when changing dressings) so talimogene laherparepvec is not transferred to any other areas of the body or other people. Also alert patients to avoid exposing others to their body fluids (such as by using condoms or avoiding contact if open sores) and to avoid close contact with pregnant women or those with weakened immune systems during their talimogene laherparepvec therapy. Talimogene laherparepvec is not for use in pregnant women or immunocompromised patients because of the risk of herpes virus infection. Immunocompromised or pregnant health care providers should not prepare or administer the drug or come in contact with injection sites, dressings, or bodily fluids from treated patients. The dosing of talimogene laherparepvec is based on lesion size but should not exceed a total of 4 mL per treatment session regardless if all lesions are injected. Hazardous waste disposal and handling procedures are necessary. Talimogene laherparepvec (Imlygic)Manufacturer: BioVex/AmgenDrug class: Antineoplastic agent (oncolytic virus)Indication: Treatment of unresectable lesions (subcutaneous and nodal) in patients with recurrent melanomaDosage: Administer via intralesional injection into cutaneous, subcutaneous, and/or nodal melanoma lesions. Dosing is based on lesion size (see prescribing information) with a starting dose of up to 4 mL (at a concentration of 106 [1 million] plaque-forming units [PFU] per mL) and subsequent doses (3 weeks after initial treatment and then 2 weeks after previous treatment) up to 4 mL at a concentration of 108 [100 million] PFU per mL. Not all lesions may be injected if the total injection volume required is more than 4 mL during a treatment session. Treatment duration is at least 6 months.Of note: Two different strengths are available: 106 PFU per mL (light green cap) and 108 PFU per mL (royal blue cap) for initial and subsequent doses, respectively. Provide the FDA-approved medication guide to patients receiving talimogene laherparepvec. Talimogene laherparepvec (Imlygic)Manufacturer: BioVex/AmgenDrug class: Antineoplastic agent (oncolytic virus)Indication: Treatment of unresectable lesions (subcutaneous and nodal) in patients with recurrent melanomaDosage: Administer via intralesional injection into cutaneous, subcutaneous, and/or nodal melanoma lesions. Dosing is based on lesion size (see prescribing information) with a starting dose of up to 4 mL (at a concentration of 106 [1 million] plaque-forming units [PFU] per mL) and subsequent doses (3 weeks after initial treatment and then 2 weeks after previous treatment) up to 4 mL at a concentration of 108 [100 million] PFU per mL. Not all lesions may be injected if the total injection volume required is more than 4 mL during a treatment session. Treatment duration is at least 6 months.Of note: Two different strengths are available: 106 PFU per mL (light green cap) and 108 PFU per mL (royal blue cap) for initial and subsequent doses, respectively. Provide the FDA-approved medication guide to patients receiving talimogene laherparepvec. Talimogene laherparepvec (Imlygic)Manufacturer: BioVex/AmgenDrug class: Antineoplastic agent (oncolytic virus)Indication: Treatment of unresectable lesions (subcutaneous and nodal) in patients with recurrent melanomaDosage: Administer via intralesional injection into cutaneous, subcutaneous, and/or nodal melanoma lesions. Dosing is based on lesion size (see prescribing information) with a starting dose of up to 4 mL (at a concentration of 106 [1 million] plaque-forming units [PFU] per mL) and subsequent doses (3 weeks after initial treatment and then 2 weeks after previous treatment) up to 4 mL at a concentration of 108 [100 million] PFU per mL. Not all lesions may be injected if the total injection volume required is more than 4 mL during a treatment session. Treatment duration is at least 6 months.Of note: Two different strengths are available: 106 PFU per mL (light green cap) and 108 PFU per mL (royal blue cap) for initial and subsequent doses, respectively. Provide the FDA-approved medication guide to patients receiving talimogene laherparepvec. Manufacturer: BioVex/Amgen Drug class: Antineoplastic agent (oncolytic virus) Indication: Treatment of unresectable lesions (subcutaneous and nodal) in patients with recurrent melanoma Dosage: Administer via intralesional injection into cutaneous, subcutaneous, and/or nodal melanoma lesions. Dosing is based on lesion size (see prescribing information) with a starting dose of up to 4 mL (at a concentration of 106 [1 million] plaque-forming units [PFU] per mL) and subsequent doses (3 weeks after initial treatment and then 2 weeks after previous treatment) up to 4 mL at a concentration of 108 [100 million] PFU per mL. Not all lesions may be injected if the total injection volume required is more than 4 mL during a treatment session. Treatment duration is at least 6 months. Of note: Two different strengths are available: 106 PFU per mL (light green cap) and 108 PFU per mL (royal blue cap) for initial and subsequent doses, respectively. Provide the FDA-approved medication guide to patients receiving talimogene laherparepvec. Patient counselingWomen of childbearing potential should use effective contraception and should not breastfeed during treatment with talimogene laherparepvec. Counsel patients to avoid touching injection sites or injection site dressings (wear gloves when changing dressings) so talimogene laherparepvec is not transferred to any other areas of the body or other people. Also alert patients to avoid exposing others to their body fluids (such as by using condoms or avoiding contact if open sores) and to avoid close contact with pregnant women or those with weakened immune systems during their talimogene laherparepvec therapy. Patient counselingWomen of childbearing potential should use effective contraception and should not breastfeed during treatment with talimogene laherparepvec. Counsel patients to avoid touching injection sites or injection site dressings (wear gloves when changing dressings) so talimogene laherparepvec is not transferred to any other areas of the body or other people. Also alert patients to avoid exposing others to their body fluids (such as by using condoms or avoiding contact if open sores) and to avoid close contact with pregnant women or those with weakened immune systems during their talimogene laherparepvec therapy. Patient counselingWomen of childbearing potential should use effective contraception and should not breastfeed during treatment with talimogene laherparepvec. Counsel patients to avoid touching injection sites or injection site dressings (wear gloves when changing dressings) so talimogene laherparepvec is not transferred to any other areas of the body or other people. Also alert patients to avoid exposing others to their body fluids (such as by using condoms or avoiding contact if open sores) and to avoid close contact with pregnant women or those with weakened immune systems during their talimogene laherparepvec therapy. Women of childbearing potential should use effective contraception and should not breastfeed during treatment with talimogene laherparepvec. Counsel patients to avoid touching injection sites or injection site dressings (wear gloves when changing dressings) so talimogene laherparepvec is not transferred to any other areas of the body or other people. Also alert patients to avoid exposing others to their body fluids (such as by using condoms or avoiding contact if open sores) and to avoid close contact with pregnant women or those with weakened immune systems during their talimogene laherparepvec therapy.