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news.AstraZeneca has received orphan drug designation from the US Food and Drug Administration for selumetinib as an adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).
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About 60,000 people in the US are diagnosed with DTC per year, and radioactive iodine (RAI) is recommended for those with known/suspected metastases at diagnosis and at high risk of recurrence.
Selumetinib, which inhibits the MEK pathway in cancer cells to avoid tumour growth, is being tested in the phase III Astra trial in DTC patients who are at high risk of recurrence.
In a phase II study of selumetinib in patients with advanced thyroid cancer, clinically meaningful increases in iodine uptake and retention were observed in patients with thyroid cancer that was refractory to RAI.
AstraZeneca executive vice president, global medicines development and chief medical officer Sean Bohen said: "Uptake of RAI is crucial for patients with thyroid cancer where no other therapies have proven beneficial.
"Selumetinib could significantly enhance currently available treatment options for these patients. The Orphan Drug Designation is an important achievement as we advance our development plans for this potential treatment in differentiated thyroid cancer."
Apart from DTC, selumetinib is being tested in the Select-1 Phase III trial of patients with KRAS-mutant advanced non-small cell lung cancer.
It is also being assessed in a phase II registration trial of paediatric and adolescent patients with neurofibromatosis Type 1 in collaboration with the US National Cancer Institute.
US-based Array BioPharma sold exclusive global rights of selumetinib to AstraZeneca in 2003.
Array has earned $26.5m in up-front and milestone payments and is entitled to receive about $30m in potential additional development milestone payments and royalties on product sales.
Image: AstraZeneca Headquarters, London, United Kingdom. Photo: courtesy of AstraZeneca.