Iressa Licensed in Europe to Treat Non-Small Cell Lung Cancer

AstraZeneca’s cancer drug Iressa (gefitinib) has been licensed in Europe as a treatment for non—small cell lung cancer (NSCLC). The approval of this oral medication follows the results of the Iressa Pan-Asia Study (IPASS), in which it demonstrated superior progression-free survival compared with intravenous carboplatin/paclitaxel chemotherapy. “I think this is an important step forward,” said Nicholas Thatcher, MB, BChir, FRCP, PhD, and professor of Medical Oncology at the Christie Hospital in Manchester, United Kingdom.

In the IPASS trial, Iressa was found to slow the growth of cancer in patients who carry a specific epidermal growth factor receptor (EGFR) gene mutation, while also improving quality of life. Thatcher explains that the EGFR mutation is present in about 40% of patients with lung cancer in Southeast Asia, but in only roughly 10% of patients with lung cancer in the European Union. With lung cancer the major cause of cancer death in the European Union, however, and with NSCLC representing ~30,000 cases a year in the United Kingdom, Thatcher believes many patients stand to benefit from gefitinib.

“Three thousand deaths a year from a cancer is clearly important,” he said. “It’s in the same ballpark as melanoma and some forms of leukemia. So while the gefitinib license in Europe may benefit a minority, it is an important minority: patients with advanced [EGFR mutated] NSCLC.”

The challenge, said Thatcher, is to make sure that EGFR mutation testing can be performed quickly and accurately. Blood tests, he explained, are not yet fully developed and their level of accuracy has not been validated. As a result, physicians will need to send biopsy samples to an accredited laboratory for mutation testing. “The medication is not licensed for use on a hit-or-miss basis,” he pointed out. “It’s licensed for use only in patients who have the EGFR-sensitizing mutation.”

The drug is not a cure for lung cancer, but Thatcher noted that its ability to slow disease progression while improving quality of life could give patients extra months to spend with their loved ones. He added that among the medical community in Britain, news of the licensing has “generally been very well received.”

Gefitinib is not an approved treatment in the United States, except in patients in clinical trials who previously demonstrated response to the drug. With positive data from IPASS and other trials (in largely Asian populations), AstraZeneca may file for approval for gefitinib in the United States for patients with EGFR-mutated NSCLC.