publication date: May. 1, 2014
FDA Approves Cyramza for Stomach Cancer;
Zykadia in NSCLC; Lipiodol for HCC Imaging;
And Cobas HPV Test for Primary Screening
FDA approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma.
Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for unresectable or metastatic cancers that have been treated with a fluoropyrimidine- or platinum-containing therapy.
Cyramza’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo.
Results showed participants treated with Cyramza experienced a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo.
Additionally, participants who took Cyramza experienced a delay in tumor growth compared to participants who were given placebo. Results from a second clinical trial that evaluated the efficacy of Cyramza plus paclitaxel versus paclitaxel alone also showed an improvement in overall survival.
The FDA reviewed Cyramza, marketed by Eli Lilly, under its priority review program and was also granted orphan product designation.
FDA granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of metastatic non-small cell lung cancer.
Zykadia is the fourth drug with breakthrough therapy designation to receive FDA approval. It is being approved four months ahead of the product’s goal date of Aug. 24. The FDA had also granted Zykadia priority review and orphan product designations.
Zykadia is an anaplastic lymphoma kinase … Continue reading TCCL April – Drug Approvals
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