Actemra CAR-T-Related Indication Comes With Help From Novartis, Kite, US FDA

 
• By Sue Sutter
  
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Genentech's interleukin-6 inhibitor got bonus approval based on data from development programs for Novartis' and Kite's chimeric antigen receptor T-cell therapies; CAR-T developers allowed FDA to access the Actemra-related data in their applications and conduct its own pooled analysis.

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FDA approved Genentech's Actemra for treating CAR-T cell-related cytokine release syndrome

A new Actemra (tocilizumab) indication for an adverse event associated with chimeric antigen receptor T-cell therapy resulted from an unusual collaboration between product sponsor Genentech Inc., the two leading CAR-T product developers, and the US FDA, which showed a high degree of flexibility as to the source and type of data sufficient to support the new claim.

On Aug. 30, FDA approved a supplemental indication for tocilizumab, an interleukin-6 (IL-6) inhibitor, for adult and pediatric patients two...

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