FDA Committee Backs AstraZeneca's Vandetanib For Narrower Population Of Thyroid Cancer Patients
This article was originally published in The Pink Sheet Daily
Executive Summary
Majority of the Oncologic Drugs Advisory Committee members support use in patients with progressive or symptomatic medullary thyroid cancer, a more limited indication than that proposed by the sponsor.
You may also be interested in...
AstraZeneca's Vandetanib Approval Includes REMS With Distribution Restrictions
The medullary thyroid cancer drug's Risk Evaluation and Mitigation Strategy requires mandatory enrollment and certification of prescribers and pharmacists, which should help ensure the drug is used primarily in patients with symptomatic, progressive disease.
AstraZeneca's Vandetanib Approval Includes REMS With Distribution Restrictions
The medullary thyroid cancer drug's Risk Evaluation and Mitigation Strategy requires mandatory enrollment and certification of prescribers and pharmacists, which should help ensure the drug is used primarily in patients with symptomatic, progressive disease.
FDA Sends Sutent sNDA For Pancreatic Cancer To ODAC
Oncologic Drugs Advisory Committee's April 12 review may have been spurred by any number of issues in the Phase III trial, including its early termination, reliability of progression-free survival assessments and failure to show quality-of-life improvements.