Trial Receives FDA Green Light to Proceed Evaluating EVX-01, Keytruda Combo in Metastatic Melanoma


A phase 2 trial evaluating EVX-01 plus Keytruda (pembrolizumab) in patients with metastatic melanoma may continue, the FDA said.

Evaxion Biotech, a Denmark-based biotechnology company, may proceed with a phase 2b clinical trial evaluating EVX-01 in combination with Keytruda (pembrolizumab) for the treatment of patients with metastatic melanoma, according to a press release from the company.

The approval from the Food and Drug Administration (FDA) to continue the trial comes after the company submitted an Investigational New Drug Application and Fast Track designation application to the FDA for the trial.

“Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program,” said Dr. Erik Heegaard, chief medical officer at Evaxion, in the release. “EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma. Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine.”

A response to the Fast Track designation, which is granted to a drug that has potential to treat a serious condition or fulfill and unmet need, is expected in the first quarter of this year. The purpose is to expedite the development and review process.

The trial was first initiated in Australia in September of 2022 and will continue across sites there, as well as the United States and Europe.

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