April 15, 2015
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FDA grants orphan drug designation to tremelimumab for malignant mesothelioma

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The FDA today granted orphan drug designation to tremelimumab — an anti-CTLA–4 monoclonal antibody — for the treatment of patients with malignant mesothelioma, according to a press release from the drug’s manufacturer.

Tremelimumab (AstraZeneca) is designed to stimulate the immune system to destroy cancer cells through binding to the protein CTLA-4, expressed on the surface of activated T-lymphocytes.

“There is a significant need for new treatment options for patients with mesothelioma because fewer than five percent of patients currently survive beyond five years, even when they receive timely diagnosis and care,” Robert Iannone, senior vice president, head of immuno-oncology global medicines development at AstraZeneca, said in a press release. “Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients.”

In addition to being evaluated as a monotherapy for the treatment of patients with mesothelioma, tremelimumab is also being studied in combination with MEDI4736 (AstraZeneca) — an anti-PD–L1 investigational immunotherapy — in non–small cell lung cancer and head and neck cancers.

Tremelimumab is also being evaluated in combination with gefitinib (Iressa, AstraZeneca) in EGFR-mutated NSCLC and with MEDI6469 (AstraZeneca) — a murine OX40 agonist — in solid tumors.

The FDA’s 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.