publication date: May. 1, 2014
20140501 - May. 1, 2014
April 2014PDF

 

Drug Approvals

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. 

Prostate Cancer 
Phase III Custirsen/Docetaxel/Prednisone Trial Fails Primary Endpoint of Overall Survival

Top-line results from a phase III trial evaluating the addition of custirsen to standard first-line docetaxel/prednisone therapy did not meet its primary endpoint of a statistically significant improvement in overall survival in men with metastatic castrate-resistant prostate cancer when compared to docetaxel/prednisone alone.

Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance.

Thyroid Cancer
Oral Sorafenib Trial Published in The Lancet; Tablets Extend PFS in Metastatic Disease

Last year, a phase III trial demonstrated Nexavar (sorafenib) tablets significantly extended progression-free survival in locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.

Results from the trial, named DECISION, were recently published in The Lancet. Based on these data, Nexavar was approved by FDA in November 2013.

Melanoma
Phase III Trial Fails to Extend OS After Meeting Primary Endpoint Of Durable Response Rate
Breast Cancer

 

Non-Small Cell Lung Cancer
LDK378 Demonstrates 58 Percent Overall Response Rate in Phase I
Survivorship
ASCO Releases Three Guidelines For Cancer Survivorship Care
NCI Approved Trials for the Month of April
More Drug Approvals

  • FDA approves sBLA for Arzerra in CLL
  • FDA and European Commission grant orphan status to volasertib in AML
  • CHMP issues positive opinion for Mekinist in metastatic melanoma
  • sNDA submitted for Imbruvica in CLL and SML based on phase III data

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