Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on developing novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for cancer patients, has received approval from the U.S. Food and Drug Administration (FDA) for AMTAGVI™ (lifileucel) suspension for intravenous infusion. This marks a significant milestone as AMTAGVI becomes the first tumor-derived autologous T cell immunotherapy to secure FDA approval for treating adult patients with unresectable or metastatic melanoma. This approval is granted for patients who have previously received treatment with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The FDA's decision is based on overall response rate (ORR) and duration of response, and Iovance is concurrently conducting TILVANCE-301, a Phase 3 trial to further validate its clinical benefits.

AMTAGVI represents a breakthrough in personalized medicine, utilizing patient-specific TIL cells to target and eliminate cancer cells. By leveraging a proprietary process, AMTAGVI is manufactured to collect and expand a patient's unique T cells from their tumor, and then reintroduce billions of these cells into the body to combat cancer.

Iovance, emphasized the company's commitment to advancing cell therapy to benefit patients with solid tumors. With approximately 8,000 deaths from melanoma annually in the U.S., the approval of AMTAGVI provides hope for patients whose disease has progressed despite prior treatments.

The FDA's decision was based on compelling safety and efficacy data from the C-144-01 clinical trial. This trial demonstrated promising responses among patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy. Notably, the primary analysis set showed a 31.5% objective response rate (ORR) with a median duration of response not yet reached at 18.6 months follow-up.

AMTAGVI will be manufactured at the Iovance Cell Therapy Center (iCTC) in Philadelphia, with plans for expansion to accommodate several thousand patients annually. The therapy must be administered at Authorized Treatment Centers (ATCs), and a comprehensive support program, IovanceCares™, has been established to assist patients and ATCs throughout the treatment process.

 

Source: globenewswire.com

Report Abuse