FDA Approves New Drug for Advanced Lung Cancer
Lung Cancer Clinical Trial and FDA Approval
Promising results from a clinical trial led by lung cancer specialist, Alan Sandler, M.D., director of Thoracic Oncology at Vanderbilt-Ingram Cancer Center, have helped in the effort to get a new drug approved by the Food and Drug Administration to fight an advanced form of the disease.
The trial involved the drug bevacizumab, now marketed as Avastin, being tested in nearly 900 patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) who had not received any prior chemotherapy. The study was part of the Eastern Cooperative Oncology Group (ECOG), one of the largest clinical cancer research organizations in the United States, and involved over 150 other study sites across the country. The patients were randomized and half received the new drug in addition to chemotherapy; the other half of the group received chemotherapy alone, which is the standard treatment option.
Patients who received Avastin combined with chemotherapy lived, on average, about two months longer than the group who only received chemotherapy. Sandler said it might not sound like a huge improvement, but for patients with this advanced, and often deadly, form of lung cancer, it is a major advancement. "Patients overwhelmingly want to live longer. It is important to note, these numbers represent an 'average;' some patients may not achieve any benefit while some patients may receive a survival benefit far beyond the two-month average."
In addition, the study also showed that some patients who received the drug plus chemotherapy saw their tumors shrink or go away altogether. Sandler said the results were groundbreaking.
"This is the first time in more than 10 years that we have