AstraZeneca receives US approval for Iressa
pharmafile | July 16, 2015 | News story | Medical Communications, Sales and Marketing | AstraZeneca, FDA, Iressa, lung cancer, non-small cell lung cancer
AstraZeneca’s lung cancer therapy Iressa has been approved by the FDA – four years after the company pulled it from the US market following disappointing clinical trial results.
Iressa (gefitinib) will be available as a first-line therapy for patients with metastatic non-small cell lung cancer (NSCLC) and specific gene mutations whose tumours have epidermal growth factor receptor (EGFR).
Iressa works by blocking the activity of the EGFR tyrosine kinase enzyme involved in the growth and survival of cancer cells. The drug was granted Orphan Drug Designation by the FDA in August 2014 for the treatment of EGFR mutation-positive NSCLC.
Antoine Yver, head of oncology global medicines development at AstraZeneca says: “The approval of Iressa provides physicians and patients in the US with a new choice of first-line treatment for metastatic non-small cell lung cancer. AstraZeneca is at the forefront of research into targeted therapies for EGFR mutated lung cancer and is committed to improving the outlook for patients at all stages of the disease.”
First approved in the US as a third-line treatment in 2003, Iressa failed to show an improvement in overall survival in a wider placebo-controlled cancer trial – leading to AstraZeneca restrict its sale in 2005 and eventually taking the drug off the market in 2011.
The new approval of Iressa has been made possible due to the development of a companion diagnostic test developed by UK firm Qiagen, which selects the patients most likely to respond to treatment, based on their tumour tissue samples.
Approved in 91 countries, the FDA approval is based on data from the Iressa Follow-Up Measure study, which assessed Iressa as a first-line treatment for Caucasian patients with locally advanced or metastatic EGFR mutation-positive NSCLC, and was supported by results from a clinical trial based on an Asian patient population.
In addition to the renewed approval, AstraZeneca is collaborating with Vida to create a live coaching app focused on health and wellness for heart attack patients, in a new programme called Day-by-Day.
The AstraZeneca Day-by-Day program works by referring heart attack patients to use a Vida coach for weight loss and overall well-being focusing on diabetes, blood pressure control and reducing stress. The program will also cover the medical fees of their patients in participating hospitals and health facilities who meet the criteria.
“This program represents our commitment to impacting health outcomes in ways beyond the medicines we make, to creating more holistic, personalized, two-way engagements with patients during times when they need it most,” says AstraZeneca’s vice president of global commercial excellence John McCarthy. “We are committed to developing innovative solutions to current and future healthcare challenges that ultimately impact patient health.”
Yasmita Kumar
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