FDA grants AstraZeneca immune drug orphan status
pharmafile | April 15, 2015 | News story | Sales and Marketing | AstraZeneca, FDA, Iressa, MEDI4736, MedImmune, NSCLC, US, gefitinib, non-small cell lung cancer, tremelimumab
The US Food and Drug Administration has granted orphan drug designation to AstraZeneca’s anti-CTLA-4 monoclonal antibody tremelimumab for the treatment of malignant mesothelioma.
Tremelimumab is one of a few immuno-oncology assets being developed by AstraZeneca and its biologics research and development arm, MedImmune, which are designed to harness the body’s own immune system to fight cancer.
Now its antibody offering has been awarded the potentially lucrative orphan designation which aims to encourage drug development for rare conditions by the FDA. Tremelimumab will get to enjoy seven years of marketing exclusivity for being defined as a treatment fighting rare diseases that affect fewer than 200,000 people in the US.
“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,” says Robert Iannone, senior VP and head of Immuno-oncology at AstraZeneca.
Tremelimumab is a fully human monoclonal antibody which stimulates the immune system to destroy cancer cells through binding to the protein CTLA-4, expressed on the surface of activated T-lymphocytes.
In addition to being investigated as a monotherapy treatment for patients with mesothelioma, it is also being looked at in combination with AstraZeneca’s anti PD-L1 investigational immunotherapy, MEDI4736, in tumour types including non-small cell lung cancer (NSCLC) and head and neck cancer.
It is also being studied in combination with Iressa (gefitinib) in EGFR mutated non-small cell lung cancer and with MEDI6469 (a murine OX40 agonist) in solid tumours.
Iressa was approved more than a decade ago to treat advanced EGFR mutation-positive NSCLC, and made sales of $316m in the first six months of 2014, a small decline thanks to increased competition in the NSCLC category.
Now AstraZeneca aims to submit tremelimumab for regulatory approval in the first half of 2016 as a treatment for mesothelioma – which is an aggressive disease that most often affects the lining of the lungs and abdomen.
Brett Wells
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