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# Orphan Drug Status for OncoSec Melanoma Therapy
- URL: https://www.fdaweb.com/orphan-drug-status-for-oncosec-melanoma-therapy/
- Published: 2017-06-09T12:00:00.000Z
- Updated: 2026-09-14T22:28:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138899

FDA has granted an OncoSec Medical an orphan drug designation for ImmunoPulse IL-12 (tavokinogene telsaplasmid) for treating unresectable metastatic melanoma. OncoSec is beginning a pivotal trial called PISCES trial to evaluate the safety and efficacy of ImmunoPulse IL-12 and pembrolizumab (Merck’s Keytruda) in patients with metastatic melanoma following disease progression on previous treatment with an anti-PD-1 therapy. Eligible patients will be those with Stage III/IV metastatic melanoma and the primary endpoint is an overall response rate.