Recent FDA Approvals for the Melanoma Community

The Melanoma Research Foundation (MRF) is pleased to share recent significant achievements for the melanoma community. In March 2022, the U.S. Food and Drug Administration (FDA) granted Iovance Biotherapeutics, Inc. an Investigational New Drug Application (IND) approval for their treatment of metastatic melanoma and Stage III or IV non-small cell lung cancer for a genetically modified Tumor Infiltrating Lymphocyte (TIL) therapy. Clinical trials are expected to begin soon.

We applaud the MRF advocates and entire patient community who participated in previous clinical trials and offered their valuable perspective to help lead to this new approval.

Read more about Iovance’s IND approval here.

In other exciting news, Bristol Myers Squibb (BMS) announced the FDA’s approval of Opdualag, the fixed-dose combination of relatlimab plus nivolumab, for the treatment of adult and pediatric patients aged 12+ years with unresectable or metastatic melanoma. This novel combination of two immunotherapies may help improve anti-tumor response by targeting two different checkpoints. This is truly novel for the pediatric melanoma population who have had limited treatment options.

Read more about the fixed-dose combination treatment here.

*Editorial update (9/16/22) – In September 2022, BMS announced the European Commission’s (EC) approval of the fixed-dose combination of Opdualag. To learn more about Opdualag’s European Union approval, visit here.

Additionally, this year began with historic news for the ocular melanoma (OM) community. In January, the FDA announced the approval of KIMMTRAK (tebentafusp-tebn), the first and only FDA-approved treatment for metastatic uveal melanoma, developed by Immunocore. The approval follows Phase III clinical trial data that showed a statistically and clinically meaningful overall survival benefit in unresectable or metastatic uveal melanoma.

The MRF is committed to supporting research advances that lead to new treatment breakthroughs for the patients and caregivers in the melanoma community. To learn more about our diverse scientific agenda and ways to get involved as a patient, caregiver, researcher or supporter, visit the MRF Research Center.