AstraZeneca's Vandetanib Approval Includes REMS With Distribution Restrictions
This article was originally published in The Pink Sheet Daily
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.
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CDER now granting 86% of sponsors’ preferred proprietary names prior to launch – a significant improvement over just five years ago that seems driven in part by several new guidance documents.
FDA’s Center for Drug Evaluation & Research is now granting 86% of drug sponsors’ preferred proprietary trade names prior to launch – a significant improvement over just five years ago. Better communication between FDA and drugs sponsors – including the development of several new guidance documents – has resulted in a much more predictable review of proprietary trade names.
Approved two months early, tyrosine kinase inhibitor’s labeling reflects 14.7-month progression-free survival improvement in patients with differentiated thyroid cancer, almost triple the benefit seen with Bayer/Amgen’s sorafenib.