FDAnews
www.fdanews.com/articles/175598-fda-awards-sellas-life-sciences-orphan-drug-status-for-wt1-cancer-vaccine

FDA Awards Sellas Life Sciences Orphan Drug Status for WT1 Cancer Vaccine

March 4, 2016

The FDA has granted orphan drug designation to Sellas Life Sciences’ WT1 cancer vaccine for the treatment of malignant pleural mesothelioma.

Sellas expects to start a pivotal Phase 2b/3 trial of the candidate in patients with MPM by the third quarter.

The agency granted orphan drug designation to the vaccine for patients with acute myeloid leukemia.  A Phase 3 study in AML is expected to start in the second quarter.