Ramucirumab First FDA-Approved Drug for Advanced Stomach Cancer after Chemotherapy

VBCC - June 2014 Vol 5, No 5 - FDA Approvals, News & Updates

The US Food and Drug Administration (FDA) approved ramucirumab (Cyramza; Eli Lilly) for the treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, which mostly affects older adults. Ramucirumab is an angiogenesis inhibitor that blocks the blood supply to tumors and is intended to be used in patients with unresectable cancer or with metastatic stomach cancer after receiving chemotherapy with a fluoropyrimidine- or a platinum-containing agent. This is the first FDA-approved therapy for patients with stomach cancer who have already received chemotherapy.

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Cyramza is a new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”

Ramucirumab was approved under the FDA’s priority review program, and was also granted an orphan drug status, because it is intended to treat rare conditions.

The safety and efficacy of ramucirumab were demonstrated in a clinical trial of 355 patients with unresectable or metastatic stomach or gastroesophageal junction cancer. Patients were randomized to ramucirumab (66%) or to placebo (34%). The main end point was overall survival (OS). The median OS was 5.2 months with ramuciru­mab compared with 3.8 months with placebo (P <.001). Ramucirumab also improved patients’ progression-free survival compared with placebo. A second trial comparing ramucirumab plus paclitaxel versus paclitaxel alone also showed an OS improvement with the addition of ramucirumab.

Common adverse events reported with ramucirumab in clinical trials include diarrhea and high blood pressure. The recommended dose of ramucirumab is 8 mg/kg every 2 weeks, administered over 60 minutes until disease progression or unacceptable toxicity. (April 21, 2014)

Related Items
FDA News - December 2017
VBCR - December 2017, Vol 6, No 5 published on December 19, 2017 in FDA Approvals, News & Updates
FDA News - October 2017
VBCR - October 2017, Vol 6, No 4 published on October 20, 2017 in FDA Approvals, News & Updates
Scott Gottlieb, MD, Appointed as New FDA Commissioner
VBCR - June 2017, Vol 6, No 2 published on June 29, 2017 in FDA Approvals, News & Updates
New Drugs Approved for Giant-Cell Arteritis and Moderate-to-Severe Rheumatoid Arthritis
VBCR - June 2017, Vol 6, No 2 published on June 29, 2017 in FDA Approvals, News & Updates
FDA Releases Draft Guidances on Sharing Healthcare Economic Information, Industry Communication Regulations
Leslie Wyatt
VBCR - April 2017, Vol 6, No 1 published on May 3, 2017 in FDA Approvals, News & Updates
FDA News - December 2016
VBCR - December 2016, Vol 5, No 6 published on January 5, 2017 in FDA Approvals, News & Updates
FDA Approves First Tissue-Engineered Autologous Cellularized Scaffold Product for the Repair of Cartilage Defects
Web Exclusives published on December 15, 2016 in FDA Approvals, News & Updates, In the News
FDA News - November 2016
VBCN - November 2016 Volume 3, No 3 published on November 22, 2016 in FDA Approvals, News & Updates
Abuse-Deterrent Oxycodone Extended-Release Capsules Approved for Chronic Pain
Web Exclusives published on November 7, 2016 in FDA Approvals, News & Updates, In the News
FDA News - October 2016
VBCR - October 2016, Vol 5, No 5 published on November 2, 2016 in FDA Approvals, News & Updates
Last modified: July 1, 2014
  • Rheumatology Practice Management
  • Lynx CME
  • American Health & Drug Benefits
  • Value-Based Cancer Care
  • Value-Based Care in Myeloma
  • Value-Based Care in Neurology