There’s a New Drug for a Specific Late-Stage Lung Cancer

The FDA has finally given its nod of approval to Iressa (getfinitib) developed by AstraZeneca to treat and delay the progression of the disease for patients with metastatic non-small cell lung cancer (NSCLC) with EGFR (epidermal growth factor receptor) mutations.

The drug was previously approved for use only in patients who did not respond to chemotherapy.

LONDON-Pharmaceutical firm AstraZeneca PLC (AZN.LN) said Tuesday that the U.S. Food and Drug Administration (FDA) has approved the drug Iressa (gefitinib) for treatment in patients with lung cancer.

According to the National Cancer Institute, an estimated 221,200 Americans will be diagnosed with lung cancer, and 158,040 will die from the disease this year. The current approval is intended for the treatment of patients with NSCLC and the most common types of EGFR mutations, including exon 19 deletions and exon 21 L858R substitution gene mutations.

Iressa is among a class of drugs called kinase inhibitors, which are created to block proteins the spur development of cancer cells. The test rapidly identifies EGFR mutation status through a tumour tissue sample, in order to guide the use of IRESSA in the treatment of patients with metastatic NSCLC. Patients received daily treatment with gefitinib (250 mg per day). The most commonly reported adverse events for IRESSA are diarrhoea and skin reactions including rash, acne, dry skin and pruritus.

Iressa, initially approved in 2003 for a different type of NSCLC, was later voluntarily withdrawn from the market after post-approval trials failed to verify a clinical benefit, the FDA said. The therascreen diagnostic is manufactured by Qiagen Manchester Ltd., based in the United Kingdom.