AstraZeneca announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to selumetinib (AZD6244, ARRY-142886) for the adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).

The recommended treatment for DTC in patients with known/suspected metastases at diagnosis and those at high risk of recurrence is radioactive iodine (RAI). A small number of patients do not benefit from RAI treatment due to their inability to express sufficient sodium/iodine symporter (NIS), a transporter for RAI uptake into thyroid cells. Selumetinib is being studied for its ability to increase NIS expression, adding a treatment option for those with poor response to RAI. 

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Selumetinib is currently being investigated in the ASTRA study, a randomized, double-blind, Phase 3 trial comparing the complete remission rate following a 5-week course of selumetinib or placebo and single dose adjuvant RAI therapy in patients with DTC. In addition, selumetinib is also being studied in a Phase 3 trial of patients with KRAS-mutant advanced non-small cell lung cancer (NSCLC) and in a Phase 2 registration trial of pediatric and adolescent patients with neurofibromatosis Type 1 in collaboration with the US National Cancer Institute.

Selumetinib is an investigational, oral, potent, selective MEK 1/2 inhibitor.

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