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FDA Grants Investigational New Drug Application for TIL Therapy

On March 15, the U.S. Food and Drug Administration (FDA) granted Iovance Biotherapeutics, Inc. an Investigational New Drug Application (IND) for IOV-4001, its first genetically modified tumor-infiltrating lymphocytes (TIL) therapy to treat unresectable or metastatic melanoma. A clinical study will begin this year to investigate the safety and efficacy of IOV-4001 to deliver TIL and PD-1 inhibition using a single therapy. For more information about the therapy, view the announcement press release.

The MRF has been strongly committed to ensuring the patient perspective is closely involved in the development of new treatments, creating new educational resources and advocating at the FDA and beyond for greater access and the need for new FDA-approved treatments.