FDA Approves Tudriqev, a New Melanoma Treatment

Immunotherapy has become the standard first line of defense against melanoma, the deadliest form of skin cancer, but for a meaningful share of patients, it either doesn’t work or eventually stops working. Until now, options for those patients have been limited. As reported by Dermatology Times, the FDA has granted accelerated approval to a new treatment called Tudriqev, used together with the immunotherapy drug nivolumab, for adults with advanced melanoma that kept progressing despite prior treatment.

Ahead, a brief rundown of what to know about Tudriqev, what the trial data shows and more.

How Tudriqev Works

Tudriqev is injected directly into melanoma lesions, including ones that sit deeper in the body, with imaging used to guide the process. It’s built from a modified virus designed to target tumor cells while also prompting the immune system to fight the cancer more broadly, then paired with nivolumab, a checkpoint inhibitor drug (sold under the brand name Opdivo) that helps the immune system recognize and attack cancer cells, to help sustain that response.

What the Tudriqev Trial Data Shows

In the study behind this approval, 24.2 percent of the 91 patients evaluated responded to the treatment, and for those who did, the response lasted a median of 14.1 months. The therapy also worked on tumors that hadn’t been directly injected, not just the ones treated.

Michael K. Wong, MD, PhD, primary investigator of the study, called it an important new tool for a broad range of patients. “The therapy in combination with nivolumab drives immune activation with a favorable risk-benefit profile,” he said, “and can be injected into superficial and visceral lesions.”

Side effects were mostly mild to moderate, including nausea, fatigue and injection site reactions, though serious side effects occurred in some patients, and the treatment carries warnings around infection risk from the modified virus it’s built on.

Why Tudriqev Approval Matters

Melanoma is the fifth most common cancer in the U.S. About half of patients don’t respond to standard checkpoint immunotherapy in the first place, and more than half of those who do respond eventually see their cancer progress again. Sam Guild, president of AIM at Melanoma, called the approval a meaningful step for that group. “Every year, more than 8,500 people die of melanoma in the U.S., and new treatment options are urgently needed,” Guild said.

For patients who’ve exhausted standard immunotherapy, Tudriqev offers something that’s been in short supply: a second-line option built specifically for their situation, delivered straight into the tumor rather than through another round of infusions.