Less than two weeks after winning the first FDA approval for a T-cell therapy for a solid tumor indication, Iovance says its U.S. launch is fully underway.
The drugmaker shared an update on Amtagvi, approved on February 16, amid its recent financial report. According to Iovance, since approval, at least 20 advanced melanoma patients have begun treatment, which includes 10 patients already registered in the company's treatment portal, with scheduled or pending manufacturing slots.
The company began commercial manufacturing for Amtagvi patients within a week of approval at its Philadelphia-based Iovance Cell Therapy Center (iCTC). According to Iovance, the iCTC plus a nearby FDA-approved contract manufacturer have the capacity to make treatments for several thousands of patients annually.
Amtagvi is a patient-specific, one-time immunotherapy utilizing T-cells to target and combat cancer cells. It is indicated for adult patients with unresectable or metastatic melanoma who have previously received treatment with a PD-1 blocking antibody and, if applicable, a BRAF inhibitor with or without a MEK inhibitor. The recent approval was based on promising overall response rates and duration of response observed in clinical trials.
