MAKE A DIFFERENCE

Make a Difference. Tell The FDA About the Importance of New Treatment Options

Recently, the U.S. Food and Drug Administration (FDA) denied the approval of a promising novel treatment known as RP1 (vusolimogene oderparepvec) in combination with the immunotherapy drug nivolumab (OPDIVO) for advanced melanoma. In a study called IGNYTE, the combination demonstrated encouraging results in patients with advanced melanoma who had failed first-line checkpoint inhibitor therapy.

This denial is a concerning setback for our skin cancer community and for drug development in general. While the FDA did not cite safety concerns, they raised issues with the IGNYTE study design that must be addressed by the sponsor of RP1 before the FDA will reconsider approving the therapy.

Your Voice Can Help

SkinCancerCare is proud to join other skin-cancer and melanoma advocacy organizations to amplify the voices of patients and caregivers affected by the FDA’s decision on RP1. Many patients with melanoma don’t respond or eventually stop responding to first-line checkpoint-inhibitor therapy, making the need for new therapies critical. We are urging the FDA to reconsider approval of this potentially life-saving treatment.

This is where you can make a difference. Your voice matters—whether you are a patient, a family member, a healthcare provider, or a concerned community member. If this is your melanoma story, please consider sharing it:

• You, or someone you support, has few treatment options for melanoma
• Your loved one died from melanoma
• You, or someone you support, has survived first-line melanoma treatment

Please share your story so that the FDA hears directly from the people most affected by this decision. Join us to make a difference and bring hope to the melanoma community.