Eli Lilly has been granted a third green light in the USA for Cyramza, this time for lung cancer.
Specifically, the US Food and Drug Administration has expanded approval of Cyramza (ramucirumab) to treat metastatic non-small cell lung cancer in combination with docetaxel. The drug, which works by blocking the blood supply that fuels tumour growth, is intended for NSCLC patients whose disease has progressed after platinum-based chemotherapy.
The latest approval is based on a study of 1,253 participants randomly assigned to receive Cyramza plus docetaxel or a placebo plus docetaxel. Results showed that half of those treated with Cyramza/docetaxel survived an average of 10.5 months from the start of treatment, compared to 9.1 months for half of the participants who received placebo/docetaxel.
Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. noted that this is the third indication granted for the drug in 2014, saying that “the commitment to study Cyramza in a variety of malignancies provides important treatment options”. The latest thumbs-up follows a priority review.
In April, the FDA approved Cyramza as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma. In November, the agency expanded its use to treat the latter patients with paclitaxel.