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Durvalumab, Tremelimumab Granted Orphan Drug Status for Liver Cancer

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The US Food and Drug Administration granted Orphan Drug Designation to durvalumab (Imfinzi) and tremelimumab for the treatment of hepatocellular carcinoma (HCC), AstraZeneca said in a press release.

Hepatocellular carcinoma is the most common type of liver cancer. According to the American Cancer Society, approximately 42,810 new cases of liver cancer will be diagnosed in 2020.1

In the ongoing Phase III HIMALAYA trial, durvalumab alone and durvalumab in combination with tremelimumab in patients with unresectable, advanced HCC who have not been treated with prior systemic therapy and are not eligible for locoregional therapy (treatment localized to the liver) is being tested.

“Many patients with liver cancer are diagnosed and treated only after the disease is advanced, and there is an urgent need for new effective and tolerable treatments. We are eager to bring new potential options to these patients and look forward to the results of our ongoing Phase III HIMALAYA trial later this year,” said José Baselga, Executive Vice President, Oncology R&D at AstraZeneca.


1 Key statistics about liver cancer. American Cancer Society. Accessed on: Jan 1 2019. Available at: https://www.cancer.org/cancer/liver-cancer/about/what-is-key-statistics.html

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