17th Apr 2015 07:16
LONDON (Alliance News) - AstraZeneca PLC on Friday said the US Food and Drug Administration has granted orphan drug designation for its selumetinib treatment for uveal melanoma, and that the latest data from its ongoing trial of AZD9291 in non-small cell lung cancer shows a delay in disease progression.
Uveal melanoma is a rare disease in which cancer cells form in the tissues of the eye, AstraZeneca said. The Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US, it added.
"Uveal melanoma is a rare and devastating disease for which there are currently no effective treatment options once it spreads beyond the tissues of the eye. Selumetinib could potentially become the first effective treatment for these patients. The Orphan Drug Designation is an important regulatory advancement as we further our development plans for selumetinib in uveal melanoma," said Antoine Yver, AstraZeneca's head of oncology in its global medicines development unit.
Data from its ongoing study of AZD9291 in patients with advanced epidermal growth factor receptor mutation positive non-small cell lung cancer who also have the T790M resistance mutation has shown a delay in disease progression of over a year, the company said.
The data showed a media progression free survival of 13.5 months. It also showed an overall response rate with AZD9291 80 milligrams of 54%, with a median duration of response of 12.4 months.
AstraZeneca said it was on track for regulatory submission of AZD9291 in the US in the second quarter of 2015.
Shares in AstraZeneca are trading up 0.4% at 4,849.50 pence Friday morning.
By Sam Unsted; [email protected]; @SamUAtAlliance. Additional reporting by Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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