FDA News
Immuno-Oncology Resource Center
FDA grants orphan drug designation to durvalumab-tremelimumab combination for liver cancer
January 21, 2020
Photo of Jose Baselga
José Baselga, MD, PhD
The FDA granted orphan drug designation to the combination of durvalumab plus tremelimumab for treatment of patients with advanced hepatocellular carcinoma.
Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1. It inhibits interaction of PD-L1 with PD-1 and CD80. Tremelimumab (MedImmune/AstraZeneca) is an investigational anti-CTLA-4 monoclonal antibody.
The ongoing phase 3 HIMALAYA trial is designed to evaluate the combination of durvalumab plus tremelimumab for patients with advanced and unresectable HCC who are ineligible for localized treatment and have not received prior systemic therapies.
The HIMALAYA trial will be the first to evaluate therapy with two immune checkpoint inhibitors as first-line treatment for advanced HCC, according to AstraZeneca.
“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,” José Baselga, MD, PhD, executive vice president of oncology research and development at AstraZeneca, said in a company-issued press release. “We are eager to bring new potential options to these patients and look forward to the results of our ongoing phase 3 HIMALAYA trial later this year.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.作者: StephenW 时间: 2020-1-22 19:52
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免疫肿瘤学资源中心
FDA授予durvalumab-tremelimumab联合治疗肝癌的孤儿药称号
2020年1月21日
Jose Baselga的照片
医学博士JoséBaselga