AstraZeneca PLC announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Iressa (gefitinib, ZD1839) for the treatment of advanced non-small-cell lung cancer (NSCLC). The FDA approval is based upon data from Phase II trials showing 13.6 per cent of US patients achieved tumour shrinkage of at least 50 per cent, after their disease had progressed following failure of both platinum-based and docetaxel chemotherapies.
"Today's announcement offers further hope to patients suffering from advanced non-small cell lung cancer, a devastating and life-threatening disease," said Sir Tom McKillop, Chief Executive, AstraZeneca PLC. "AstraZeneca is proud to have discovered Iressa and to be the first company to deliver this new class of cancer treatment."
The effectiveness of Iressa is based on objective response rates. Most responses were seen in the first eight weeks of treatment. Iressa is a once-a-day 250 mg pill and is not typically associated with the severe side-effects often seen with standard cytotoxic chemotherapy treatments used to treat NSCLC patients. Most patients experience some side-effects but these are generally mild and well-tolerated including rash and diarrhoea. Interstitial Lung Disease (ILD) is a known complication of lung cancer and has been observed in about 1 per cent of patients taking Iressa.
The US approval reflects a recognition of the need for new treatment options for NSCLC - a complex, severely symptomatic illness with a devastating impact on patients and their families. Lung cancer is the biggest cancer killer in the world, causing more deaths each year than breast, prostate and bowel cancer put together. NSCLC is the most common form, accounting for 80 per cent of cases. In the year 2000 there were over 1.2 million people diagnosed with lung cancer world-wide and more than 1 million people died from the disease. In the United States, lung cancer will account for approximately 157,000 deaths in 2003. The total market for drugs used to treat non-small cell lung cancer in the US is estimated to be worth over $1 billion and is set to grow to $4.5 billion in 2011.
The FDA accelerated (or sub part H) approval process was created for life threatening conditions where a new drug provides meaningful therapeutic benefit over available treatments, or in the case of Iressa, where no approved therapies exist. As part of this process, AstraZeneca has agreed with FDA that it will complete a programme of Phase IV clinical studies, which are designed to further demonstrate the clinical benefits of Iressa and satisfy FDA requirements for full approval.
Iressa was approved for the treatment of inoperable or recurrent NSCLC in Japan in July 2002 and has recorded US $86 million in sales since its launch. The drug's approval was also announced in Australia on May 1st 2003. A marketing application was submitted in the European Union in February 2003. Marketing applications have also been submitted in 12 other countries with a number of these nearing completion of the review process. Additional marketing applications are planned for submission in the near future. Phase II clinical trials are also underway in other solid tumour types including colorectal, breast, head and neck and prostate cancers.