*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.1See how IMLYGIC® is different
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
Administer IMLYGIC® by intralesional injection into cutaneous, subcutaneous, and nodal lesions that are visible, palpable, or detectable by ultrasound guidance; do not administer intravenously.1Read about dosing and administration
Information on storage requirements of IMLYGIC®, as well as details on procurement, ordering, and safe handling. This video does not replace the Prescribing Information. Please review the Prescribing Information prior to handling IMLYGIC®.Learn more about IMLYGIC® storage and handling details
IMPORTANT SAFETY INFORMATION
INDICATION AND LIMITATIONS OF USE
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.