FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer

The US Food and Drug Administration has approved pemetrexed (Alimta), the first drug available for maintenance therapy of advanced or metastatic lung cancer. Pemetrexed disrupts metabolic processes that are dependent on the B-vitamin folate, a necessary ingredient for cell replication.

"This drug represents a new approach in the treatment of advanced non–small-cell lung cancer (NSCLC)," said Richard Pazdur, MD, director, Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four to six chemotherapy cycles. This study demonstrates an advantage in overall survival in certain patients who received Alimta for maintenance therapy."

In a 600-patient clinical trial, people with predominantly squamous cell cancer did not benefit from pemetrexed. But those with other subtypes of NSCLC survived an average 15.5 months following treatment compared with 10.3 months for patients who received placebo.