AstraZeneca (AZN) announced that the US Food and Drug Administration or FDA has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma.
The company stated that Uveal melanoma is a rare and devastating disease in which cancer cells form in the tissues of the eye. It is the most common primary intraocular malignancy in adults and comprises 5% of all melanomas.
Selumetinib, originally licensed from Array BioPharma Inc., inhibits the MEK pathway in cancer cells to prevent the tumour from growing. Data from a phase III study evaluating selumetinib in combination with chemotherapy in patients with first-line metastatic uveal melanoma is expected to be available later this year.
In addition to uveal melanoma, selumetinib is being investigated in Phase III studies in KRAS mutation positive lung cancer and thyroid cancer and in Phase II in children with neurofibromatosis Type, AstraZeneca stated.
The company also said that initial data from a combination study of selumetinib with other AstraZeneca pipeline molecules including AZD9291 and MEDI4736 in non-small cell lung cancer will be presented at the American Society of Clinical Oncology or ASCO annual meeting 2015.
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