AstraZeneca and Qiagen’s lung cancer drug and companion diagnostic combination receive FDA approval.

IRESSA (gefitinib) has been approved by the US. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

NSCLC is the most common type of lung cancer. Around 10 percent of NSCLC tumors have a mutation in the EGFR gene. When you consider that lung cancer is the leading cause of cancer-related death in the U.S., the benefit of increasingly targeted therapies becomes very clear.

“IRESSA offers another effective first-line therapy option for selected lung cancer patients. This approval provides further support for a highly targeted approach to treating cancer,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“In 2003, IRESSA was the first EGFR-TKI for patients with non-small cell lung cancer. While some patients showed dramatic benefit, the research at that time did not enable us to identify those patients that would benefit the most from this treatment,” said Gregory Keenan, Vice President, Medical Affairs & U.S. Head Medical Officer at AstraZeneca. “Today, our understanding of molecular mutations and molecular targeting has enabled better decision making in the treatment of NSCLC.”

A crucial part of ensuring the success of IRESSA is having the ability to efficiently identify which patients will benefit from the drug. For IRESSA, that comes in the shape of Qiagen’s companion diagnostic – the therascreen EGFR RGQ PCR Kit, which also received FDA approval.

“The approval of the therascreen EGFR RGQ PCR Kit will allow physicians to identify non-small cell lung cancer patients who are candidates for receiving IRESSA as first-line therapy,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Companion diagnostics provide information that is essential for the safe and effective use of important medications.”

“We are very pleased to offer the therascreen EGFR test in the United States to guide the use of IRESSA, a further milestone in personalized medicine for lung cancer patients. QIAGEN’s leadership in companion diagnostics continues to grow, transforming patient care around the world,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area and a member of the Executive Committee of QIAGEN. “The FDA approval of our therascreen EGFR test with IRESSA is another highlight in QIAGEN’s ongoing, successful collaboration with AstraZeneca. This marks QIAGEN’s fourth U.S. approval of a companion diagnostic. As the second FDA-approved use of therascreen EGFR in NSCLC, the pairing with IRESSA also expands QIAGEN’s U.S. market leadership in EGFR testing. Our growing Personalized Healthcare portfolio continues to broaden the content menu for Rotor-Gene Q, a member of our QIAsymphony platform family.”

“We are delighted to be partnering with QIAGEN to provide this important companion diagnostic test to guide the use of IRESSA for patients with NSCLC in the U.S. By combining AstraZeneca’s expertise in lung cancer with QIAGEN’s leading diagnostic technologies, we have the potential to help physicians achieve better patient outcomes in NSCLC,” said Ruth March, Vice President and Head of Personalized Healthcare and Biomarkers at AstraZeneca.

All in all, a good day for AstraZeneca and Qiagen, and more importantly a good day for the patients who are going to benefit from better treatment.

For the FDA’s full release, click here.

For AstraZeneca’s full release, click here.

For Qiagen’s full release, click here.