FDA Awards AZ’s Selumetinib Orphan Drug Status

The FDA granted orphan drug designation to AstraZeneca for its MEK1/2 inhibitor selumetinib as an adjuvant treatment in patients with stage 3 and 4 thyroid cancer.

The candidate also is being evaluated in a pivotal trial in patients suffering from KRAS-mutant advanced non-small cell lung cancer, and in a Phase 2 trial in patients with neurofibromatosis.