Safety specification The sponsor provided a summary of ongoing safety concerns which are shown at Table 9. Table 9: Summary of ongoing safety concerns Important identified Important potential Missing information risks risks Disseminated herpetic Disseminated herpetic Additional clinical infection in severely infection in biodistribution and immunocompromised immunocompromised shedding data in individuals (those with individuals (such as melanoma. any severe congenital or those with HIV/AIDS, acquired cellular and/or leukemia, lymphoma, humoral immune common variable deficiency). immunodeficiency, or those who require steroids or other immunosuppressive drugs. Accidental exposure of Symptomatic talimogene Recombination of HCP to talimogene laherparepvec infection talimogene laherparepvec. in non-tumour tissue in laherparepvec with treated patients. wild-type HSV-1. Cellulitis at the site of Transmission of Pregnant and lactating injection. talimogene women. laherparepvec from patient to close contacts or HCP via direct contact with injected lesions or body fluids resulting in symptomatic infection (primary of reactivation). Symptomatic herpetic Paediatric patients. infection due to latency and reactivation of talimogene laherparepvec or HSV-1 in patients. Immune-mediated Patients with renal or adverse events. hepatic impairment. Plasmacytoma at the Long-term safety data. injection site. Impaired wound healing at the site of injection.
Safety specification The sponsor provided a summary of ongoing safety concerns which are shown at Table 9. Table 9: Summary of ongoing safety concerns Important identified risks Important potential risks Missing information Disseminated herpetic infection in severely immunocompromised individuals (those with any severe congenital or acquired cellular and/or humoral immune deficiency). Disseminated herpetic infection in immunocompromised individuals (such as those with HIV/AIDS, leukemia, lymphoma, common variable immunodeficiency, or those who require steroids or other immunosuppressive drugs. Additional clinical biodistribution and shedding data in melanoma. Accidental exposure of HCP to talimogene laherparepvec. Symptomatic talimogene laherparepvec infection in non-tumour tissue in treated patients. Recombination of talimogene laherparepvec with wild-type HSV-1. Cellulitis at the site of injection. Transmission of talimogene laherparepvec from patient to close contacts or HCP via direct contact with injected lesions or body fluids resulting in symptomatic infection (primary of reactivation). Pregnant and lactating women. Symptomatic herpetic infection due to latency and reactivation of talimogene laherparepvec or HSV-1 in patients. Paediatric patients. Immune-mediated adverse events. Patients with renal or hepatic impairment. Plasmacytoma at the injection site. Long-term safety data. Impaired wound healing at the site of injection.
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