FDA Advisory Committee Recommends Approval of Genzyme's Thyrogen for Thyroid Cancer Diagnosis

Strategic Insights -

The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee has voted to recommend the approval of Genzyme General's Thyrogen, a recombinant human thyroid stimulating hormone, for use in evaluating patients being tested for thyroid cancer metastases. The panel's recommendation is not binding on the FDA but is typically followed by the agency. Thyrogen was developed to provide a safer alternative to current diagnostic testing methods, which require patients to withdraw from thyroid hormone supplements, leading to debilitating side effects.

Key Takeaways:

  • The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-3 to recommend approval of Thyrogen for use in conducting thyroid scanning and thyroglobulin testing in patients who would benefit from avoiding hypothyroidism.
  • The panel voted 11-0 to recommend approval of Thyrogen for use in patients who would otherwise be examined solely with a serum thyroglobulin test without undergoing hormone supplement withdrawal.
  • Approximately 135,000 thyroglobulin tests are performed annually in the United States for patients who have had thyroid cancer, in addition to approximately 25,000 whole body scans.
  • Similar numbers of thyroglobulin tests and whole body scans are performed in Europe.
  • Thyrogen is intended to allow diagnostic testing while avoiding hormone withdrawal and its debilitating effects.
  • The NDA for Thyrogen was accepted by the FDA under the agency's priority review process, which requires an action letter within six months of receipt.
  • Genzyme General develops and markets therapeutic and surgical products and diagnostic products and services.
  • Investors can listen to a playback of a conference call discussing the outcome of the Thyrogen panel meeting by calling 1-800-633-8284 or 303-248-1201.

Statistics:

  • 135,000 thyroglobulin tests are performed annually in the United States for patients who have had thyroid cancer.
  • 25,000 whole body scans are performed annually in the United States for patients who have had thyroid cancer.
  • Similar numbers of thyroglobulin tests and whole body scans are performed in Europe.
  • The NDA for Thyrogen was submitted on December 12, 1997.
  • The FDA reserves priority review for therapies that may substantially improve the standard of treatment for a certain disease or condition.
  • The priority review process requires the FDA to provide an action letter to the company within six months of receipt.

Sources:

  • "Genzyme General", PR Newswire, May 15, 1998.
  • "FDA Reserve Priority Review For Genzyme General's Thyrogen Application", PR Newswire, December 12, 1997.