FDA Lifts REMS Requirement For Thyroid Cancer Drug Caprelsa After Over A Decade Of Safety Review

Sanofi

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(RTTNews) - On Friday, the U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategies program for Caprelsa, a thyroid cancer medication manufactured by Genzyme Corporation, which Sanofi, a French pharmaceutical company, now owns.

A Risk Evaluation and Mitigation Strategies (REMS) program is a safety program that the FDA can require for certain medications with serious safety concerns, designed to help ensure that the benefits of the medication outweigh its risks.

Back in 2011, when the FDA first approved Caprelsa to treat medullary thyroid cancer in patients whose disease had spread or could not be surgically removed, a Risk Evaluation and Mitigation Strategies (REMS) program was required to ensure appropriate heart rhythm monitoring and safe use.

After more than a decade of evaluation, REMS assessments reported no cases of Torsades de pointes or unexplained sudden deaths among U.S. patients taking Caprelsa and no concerning patterns of heart rhythm problems in Clinical data.

This milestone for Caprelsa, chemically known as vandetanib, means that healthcare providers will no longer require special certification or additional monitoring beyond standard clinical care.

"Cancer specialists now have adequate knowledge about managing the heart rhythm related risks of this medication," said Richard Pazdur, M.D., FDA Oncology Center of Excellence Director.

Sanofi has traded within a range of $44.73 to $60.12 over the last year. The stock closed yesterday's trading at $45.07, down 2.87%.