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# FDA, Polynoma Agree on Study for Melanoma Vaccine
- URL: https://www.fdaweb.com/fda-polynoma-agree-on-study-for-melanoma-vaccine/
- Published: 2022-01-11T12:00:00.000Z
- Updated: 2026-09-14T17:28:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150906

FDA and Polynoma have reached agreement under a Special Protocol Assessment on a pivotal Phase 3 clinical trial of the company’s melanoma cancer vaccine seviprotimut-L and its use as an adjuvant treatment for patients 60 years and younger with Stage IIB or IIC melanoma following definitive surgical resection to improve recurrence-free survival. Seviprotimut-L previously received a fast track designation from the agency.

Recently published data from the Melanoma Antigen Vaccine Immunotherapy Study showed the vaccine’s clinically significant improvement in recurrence-free survival, which reduced the risk of disease recurrence or death by 68% compared to patients receiving placebo, according to the company. Additionally, recurrence-free survival was more favorable in patients under age 60 with ulcerated melanomas, and there was a trend toward improved overall survival for patients that received seviprotimut-L compared to those receiving placebo, it adds.