AstraZeneca’s Investigational Mesothelioma Drug Receives Orphan Drug Status from the FDA

US health regulators have granted Orphan Drug designation to AstraZeneca’s investigational drug in development for treatment of a rare cancer.

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted orphan status for its anti-CTLA-4 monoclonal antibody, tremelimumab, for the treatment of malignant mesothelioma. The agency provides orphan drug status to drugs intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US.

Mesothelioma is a rare, aggressive cancer that typically affects the lining of the lungs and abdomen. Treatment options are available for the condition, however they are very limited, especially for patients with advanced disease.

Tremelimumab is one of the many immuno-oncology assets in development by AstraZeneca and its biologics research arm MedImmune. Immunotherapies are designed to harness the body’s own immune system to fight cancer. The drug is a fully human monoclonal antibody, which stimulates the immune system to destroy cancer cells by 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. Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients,” said Robert Iannone, Senior Vice President, Head of Immuno-Oncology, Global Medicines Development at AstraZeneca.

In addition being studied as a monotherapy treatment for patients with mesothelioma, AstraZeneca is also testing tremelimumab in combination with its anti PD-L1 investigational immunotherapy, MEDI4736, in tumor types including non-small cell lung cancer (NSCLC) and head and neck cancer. Additionally, the drug is being studied in combination with AstraZeneca’s Iressa (gefitinib) in EGFR mutated NSCLC and with MEDI6469 in solid tumors.

Source: AstraZeneca plc

Last updated: 4/15/15; 3:25pm EST

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