22nd May 2020 09:10
(Alliance News) - AstraZeneca PLC on Friday said Enhertu has been granted orphan drug designation by the US Food & Drug Administration.
The FTSE 100-listed pharmaceutical company said its drug Enhertu - jointly-developed with Japanese peer Daiichi Sankyo Co Ltd - has been granted the designation for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.
Orphan designation is awarded to medications intended for the treatment, prevention or diagnosis of a rare disease or condition. The drug's orphan drug status means that Enhertu will benefit from a more rapid approval process, assistance from regulatory agencies during drug development, and the opportunity for market exclusivity following approval.
Astra noted that gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer mortality with a five-year survival rate of 5% for metastatic disease. It added that around 27,600 new cases of gastric cancer will be diagnosed in 2020 which could lead to more than 11,000 deaths in the US.
The designation was granted by the regulatory body based on the phase 2 DESTINY-Gastric01 trial which found that Enhertu improved overall survival in patients with HER2-positive metastatic gastric or gastroesophageal junction cancer that had progressed following two or more treatments using cancer drug trastuzumab and chemotherapy.
Shares in AstraZeneca were trading 1.3% lower at 8,845.00 pence each on Friday morning in London. Daiichi Sankyo shares closed down 1.8% at JPY8,572 in Tokyo.
By Ife Taiwo; [email protected]
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