The FDA today approved a new indication for ramucirumab for the treatment of metastatic non-small cell lung cancer.
The FDA today approved a new indication for ramucirumab (Cyramza) for the treatment of metastatic non-small cell lung cancer (NSCLC).
The drug was approved on April 21, 2014, as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction (GEJ). On November 5, 2014, it was expanded for the treatment of patients with advanced gastric or GEJ adenocarcinoma to include chemotherapy drug paclitaxel.
“Today’s approval is the third indication that Cyramza has received in 2014,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research, in a press release. “The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients.”
Ramucirumab blocks the blood supply that fuels tumor growth, and is intended for use in patients whose tumor has progressed during or following treatment with platinum-based chemotherapy. The drug is to be used in combination with chemotherapy medication docetaxel.
The approval of ramucirumab with docetaxel for the treatment of metastatic NSCLC followed a clinical trial that included 1253 participants previously treated for progressive lung cancer. The participants were randomly assigned to receive ramucirumab with docetaxel or placebo with docetaxel until the disease progressed or intolerable side effects developed.
The results showed that half of the participants in the ramucirumab plus docetaxel group survived an average of 10.5 months from the start of treatment, compared with an average of 9.1 months in the placebo with docetaxel group.
Common adverse events associated with ramucirumab plus docetaxel included a decrease in infection-fighting white blood cells, fatigue, and stomatitis. The drug can also cause severe bleeding, blood clots, elevated blood pressure, and impaired wound healing.