FDA Approves Opzulera for At-Home Therapy for Skin Repigmentation: What this Means for Melanoma Patients with Vitiligo

On July 18th, the U.S. Food & Drug Administration (FDA) approved the first topically-applied treatment for skin repigmentation for patients with vitiligo after strong results from two Phase 3 trials. Vitiligo, a chronic skin disease, affects 3 in 100 people who have melanoma, categorized as melanoma-associated vitiligo.¹ The approval invites patients with vitiligo, including those with melanoma, to talk with their providers on how Opzelura can serve their skin needs.

What is Vitilgo?

Vitiligo is a chronic autoimmune condition where the body’s immune response will target melanocytes, causing areas of the skin to lose pigment called melanin. Some patients with melanoma develop vitiligo as a side effect from checkpoint immunotherapy, where normal skin cells get caught in the crossfire between cancer cells and the medication.² Although not physically painful, living with vitiligo is emotionally and psychologically challenging and affects wellbeing.^{3, 4}

Until the July 18^th FDA approval of Opzulera, patients facing melanoma-associated vitiligo had limited treatment options, which mainly consisted of light therapy. Light therapy requires doctor visits two to three times a week for upwards of six months before any noticeable change. The newly approved therapy for vitiligo expands the available options for repigmentation care while providing a friendlier routine of applying twice daily on affected areas.

What does it mean to have one’s melanin return? For skin of color - or skin with more melanin - and for those whose vitiligo is located on more visible areas, it can be especially difficult to adjust to skin discoloration and many encounter negative stigma associated with their appearance.⁵ Restoration of melanin can signal a return of comfort and confidence for people.

What is Opzulera?

Opzulera (ruxolitinib) is a topical Janus kinase (JAK) inhibitor, which slows the body’s hyperactive inflammation to mitigate the body’s attack of normal melanocytes (which have melanin and give skin its color).⁶ In trying to heal the body from a nonexistent threat, the overstimulated process of inflammation causes damage to melanocytes.⁷ Slowing down autoimmunity invites the gradual growth of more melanin-producing cells. 

Opzulera was approved based on two Phase 3 clinical trials that assessed the safety and effectiveness of the cream in patients with non-segmental vitiligo (the most common type of vitiligo). After one year of using the experimental therapy, half of the patients treated with Opzulera achieved at least 75% improvement from their baseline facial pigmentation.^{8, 9}

The cost of Opzelura is covered by some insurances. However, not all insurance companies -consider care for vitiligo as medically necessary. This means that insurance companies may not cover Opzelura or may only do so with higher cost sharing. This is problematic because vitiligo-affected skin is more susceptible to sunburn due to the loss of melanocytes and have valid psychosocial needs.¹⁰ Learn more about insurance coverage and financial assistance programs.

If you are experiencing vitiligo as a side effect of your melanoma treatment, speak to your doctor to determine if Opzelura is right for you.