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Orphan Drugs: Eli Lilly Receives FDA Approval

April 22, 2014

Eli Lilly and Company announces on April 21st, that the FDA approves orphan drug Cyramza (Ramucirumab) injection as a single-agent treatment for patients with advanced or metastatic gastric cancer or Gastroesophageal Junction (GEJ) adenocarcinoma with disease progression on or after prior Fluoropyrimidine- or platinum-containing chemotherapy.

FDA Orphan Drug Designation Database Record

Generic Name: Ramucirumab
Trade Name: Cyramza
Date Designated: 02-16-2012
Orphan Designation: Treatment of gastric cancer
Orphan Designation Status: Designated/Approved
FDA Orphan Approval Status: Approved for Orphan Indication
Approved Labeled Indication: Treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma, as a single-agent after prior fluoropyrimidine-or platinum-containing therapy.
Marketing Approval Date: 04-21-2014
Exclusivity End Date: N\A
Sponsor: ImClone Systems LLC 33 ImClone Drive ImClone is a subsidiary of Eli Lilly Branchburg, NJ 08876 The sponsor address listed is the last reported by the sponsor to OOPD.


Cyramza is the first FDA approved treatment for patients with this indication. Eli Lilly acquired Cyramza from ImClone Systems in 2008, with the drug receiving FDA Orphan Drug Designation (ODD) in February 2012. The approval of Cyramza comes with a Boxed Warning regarding an increase risk of hemorrhage. The company plans on making the drug available in the coming weeks.

The approval of Cyramza is based on the Phase III REGARD clinical trial – a multicenter, randomized, placebo-controlled, double-blind trial with 355 patients. The trial showed an increased median overall survival by 37% (median overall survival of 5.2 months vs. 3.8 months for placebo, P=0.047). Also, Cyramza greatly improved Progression-Free Survival (PFS), demonstrating a 62% increase in median PFS (2.1 months vs. 1.3 months for placebo, P<0.001).

Gastric Cancer Statistics

•   5th most common cancer in the world

•   3rd leading cause of cancer death

•   In 2012, there were approximately 1 million new cases worldwide, with 66% for men and 34% for women.


Eli Lilly and Company Press Release

FDA News Release.

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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