FDA Grants Orphan Drug Designation to Novel Immunotherapy in Advanced Melanoma

Source: Targeted Oncology, January 2021

The FDA has granted an Orphan Drug designation to the novel immunotherapy PVSRIPO for the treatment of patients with advanced melanoma of stage IIB-IV, Istari Oncology, Inc., announced in a press release.1

The agent is under evaluation currently in a phase 2 study known as LUMINOS-102 (NCT04577807), which follows a successful phase 1 study of PVSRIPO as monotherapy in patients with anti-PD-1 refractory advanced melanoma.

“We are encouraged by the data from our phase 1 trial presented at last year’s Society for Immunotherapy of Cancer (SITC) 2020 annual meeting,” said Garrett Nichols, MD, MS, chief medical officer, Istari Oncology, in a statement.