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Jan. 20, 2020, 2:56 a.m. EST

AstraZeneca: FDA gives orphan drug status to two liver cancer drugs

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By Carlo Martuscelli

AstraZeneca PLC (AZN.LN) said Monday that two of its medicines were granted orphan drug status by the U.S. Food and Drug Administration for the treatment of a common type of liver cancer.

The designation is awarded to drugs that are intended to treat rare disease and provides benefits such as market exclusivity and faster regulatory approvals.

Imfinzi and tremelimumab were given orphan drug status as treatments for hepatocellular carcinoma, or HCC. Imfinzi is already approved for other types of cancer, while tremelimumab is currently being investigated as a potential treatment.

The two drugs are being jointly studied in the phase 3 Himalaya clinical trial as treatments for a type of inoperable and advanced HCC.

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