IMLYGIC (talimogene laherparepvec). Suspension for intralesional injection Initial U.S. Approval: 2015

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IMLYGIC (talimogene laherparepvec). Suspension for intralesional injection Initial U.S. Approval: 2015

INDICATIONS AND USAGE
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.
DOSAGE FORMS & STRENGTHS
Injection: 106 (1 million) PFU per mL, 108 (100 million) PFU per mL in single-use vials.
Manufactured By: Amgen
Prescribing Information URL: Click Here

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Talimogene laherparepvec[a] is a biopharmaceutical drug to treat melanoma that cannot be operated on; it is injected directly into a subset of lesions which generates a systemic immune response against the patient's cancer.
The drug was created and initially developed by BioVex, Inc. and was continued by Amgen, which acquired BioVex in 2011. It was the first oncolytic immunotherapy approved globally; it was approved in the US in October 2015 and approved in Europe in December 2015.

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