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US FDA approves Lilly’s Cyramza to treat aggressive non-small cell lung cancer

The US Food and Drug Administration has given its approval for the expanded use of Lilly's oncology drug, Cyramza (ramucirumab), to treat patients with metastatic non-small cell lung cancer (NSCLC).

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NSCLC occurs when cancer cells form in the lung’s tissues. According to estimates by the National Cancer Institute, about 224,210 individuals in the US are expected to be diagnosed and around 159,260 are likely to die due to lung cancer this year.

FDA Center for Drug Evaluation and Research Office of Hematology and Oncology Products director Dr Richard Pazdur said: "Today’s approval is the third indication that Cyramza has received in 2014.

"The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients."

The latest approval was obtained based on the results from a clinical study of 1,253 participants with previously treated and progressive lung cancer. The participants were randomly assigned to receive Cyramza plus docetaxel or a placebo plus docetaxel.

Designed to block the blood supply that fuels tumor growth, the drug is intended for patients whose tumor has progressed during or following treatment with platinum-based chemotherapy, and it is to be used in combination with docetaxel, another type of chemotherapy.

Cyramza received FDA approval on 21 April to act as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

The drug was also granted expanded usage approval by the FDA for advanced gastric or GEJ adenocarcinoma to include paclitaxel, another chemotherapy drug on 5 November.


Image: Eli Lilly and Company’s global headquarters, in Indianapolis, Indiana, US. Photo; courtesy of Guanaco152003.