publication date: Dec. 19, 2014
FDA Expands Cyramza Label to Include Metastatic NSCLC
FDA expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer.
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. Cyramza’s application was reviewed under the agency’s priority review program.
On April 21, the FDA approved Cyramza, sponsored by Eli Lilly & Co., as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. On Nov. 5, FDA expanded Cyramza’s use to treat patients with advanced gastric or GEJ adenocarcinoma to include paclitaxel.
The approval of Cyramza plus docetaxel for metastatic NSCLC is based on a clinical study of 1,253 participants with previously treated and progressive lung cancer. Study participants were randomly assigned to receive Cyramza plus docetaxel or a placebo plus docetaxel. Results showed that half of the participants treated with Cyramza 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.
FDA approved Somatuline Depot Injection (lanreotide) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.
Somatuline was previously approved for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Somatuline is sponsored by Ipsen Pharma.
The approval was based on demonstration of improved progression-free survival in a multi-center, international, randomized, double-blind, placebo-controlled study … Continue reading 40-47 FDA Expands Cyramza Label to Include Metastatic NSCLC
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