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Imfinzi, tremelimumab granted ODD in liver cancer
Imfinzi, tremelimumab granted ODD in liver cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 2850A AstraZeneca PLC 20 January 2020 \n\n20 January 2020 07:00 GMT\n \nImfinzi and tremelimumab granted Orphan\nDrug Designation in the US for liver cancer\n \nAstraZeneca's Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation (ODD) in the US for the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer.\n \nThe US Food and Drug Administration (FDA) grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.\n \nLiver cancer is the third leading cause of cancer death worldwide and for patients with unresectable or advanced disease, only 13% are alive five years after diagnosis.1-3\n \nJosé Baselga, Executive Vice President, Oncology R&D, said: \"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.\"\n \nThe Phase III HIMALAYA trial is testing Imfinzi and the combination of Imfinzi plus tremelimumab in patients with unresectable, advanced HCC who have not been treated with prior systemic therapy and are not eligible for locoregional therapy (treatment localised to the liver). HIMALAYA is the first trial to test dual immune checkpoint blockade in the 1st-line advanced HCC setting.\n \nImfinzi is not currently approved to treat HCC in any country, alone or in combination with tremelimumab.\n \nHepatocellular carcinoma (HCC)\nLiver cancer is the third leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.1 HCC represents about 80% of all primary liver cancers.4 Approximately 700,000 people were diagnosed with HCC around the world in 2018, and an estimated 42,000 people were diagnosed in the US last year.1,2 Between 80-90% of all patients with HCC also have chronic liver disease, which is primarily caused by infection with the hepatitis B or C viruses.5,6 Chronic liver disease is associated with inflammation that, over time, results in immunosuppression and can lead to the ...