October 27, 2015

http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM469575.pdf

On October 27, 2015, the U.S. Food and Drug Administration approved talimogene laherparepvec (IMLYGICTM, Amgen, Inc.), 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.

Talimogene laherparepvec is administered via direct injection into the recurrent, unresectable melanoma lesions.

The safety and efficacy of talimogene laherparepvec were evaluated in a multicenter study of 436 participants with metastatic melanoma that could not be surgically removed. The participants’ melanoma lesions in the skin and lymph nodes were treated with talimogene laherparepvec or granulocyte-macrophage colony-stimulating factor (GM-CSF) for at least six months, or until there were no remaining injectable lesions. The study showed that 16.3 percent of the study participants who received IMLYGIC experienced a decrease in size of their skin and lymph node lesions, lasting for a minimum of six months, compared to 2.1 percent of the study participants receiving GM-CSF. However, talimogene laherparepvec has not been shown to improve overall survival or to have an effect on melanoma that has spread to the brain, bone, liver, lungs, or other internal organs.

The safety of talimogene laherparepvec was evaluated in 419 patients who received at least 1 dose of either talimogene laherparepvec (n=292) or subcutaneously administered GM-CSF (n=127) in an open-label, randomized clinical study of patients with stage IIIB, IIIC, and IV melanoma that was not considered to be surgically resectable. The median duration of exposure to talimogene laherparepvec was 23 weeks (5.3 months). Twenty six patients were exposed to talimogene laherparepvec for at least one year.

The most common adverse drug reactions (≥ 25%) in talimogene laherparepvec-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. Most adverse reactions reported were mild or moderate in severity and generally resolved within 72 hours. The most common grade 3 or higher adverse reaction was cellulitis.

Pyrexia, chills, and influenza-like illness can occur any time during talimogene laherparepvec treatment, but were more frequent during the first 3 months of treatment.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications, is available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM469575.pdf.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).