Ramucirumab approved for metastatic non-small-cell lung cancer
Ramucirumab approved for metastatic non-small-cell lung cancer
16 Dec 2014On 12 December 2014, the USA Food and Drug Administration expanded the approved use of ramucirumab (Cyramza) to treat patients with metastatic non-small-cell lung cancer (NSCLC).
The drug, which is to be used in combination with another type of chemotherapy, docetaxel, is meant for patients whose tumor has progressed during or following treatment with platinum-based chemotherapy.
“Today’s approval is the third indication that Cyramza has received in 2014,” said Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. Ramucirumab, which is marketed by Eli Lilly, is already approved for the treatment of advanced gastric cancer or gastro esophageal junction (GEJ) adenocarcinoma and advanced gastric or GEJ adenocarcinoma in its combination with paclitaxel.
A placebo-controlled study
The approval of ramucirumab plus docetaxel for metastatic NSCLC is based on a clinical study of 1,253 participants with previously treated and progressive NSCLC. Study participants were randomly assigned to receive either (a) ramucirumab plus docetaxel or (b) a placebo plus docetaxel.
Treatment was given until disease progression or development of intolerable side effects. The trial was designed with overall survival, as primary endpoint.
Improved survival for participants treated with ramucirumab plus docetaxel
The results showed that half of the participants treated with ramucirumab plus docetaxel survived an average of 10.5 months from the start of treatment, compared to an average of 9.1 months from the start of treatment for half of the participants who received placebo plus docetaxel.
Common side effects of the drug
The most common side effects associated with Cyramza plus docetaxel included neutropaenia, fatigue and stomatitis.
Ramucirumab can cause severe bleeding, blood clots, elevation in blood pressure and may impair wound healing.
Source: European Society for Medical Oncology