Actemra CAR-T-Related Indication Comes With Help From Novartis, Kite, US FDA
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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Proactive US FDA Propelled Review Of Genentech’s Actemra In Systemic Sclerosis Amid Evolving Regulatory Landscape
Pink Sheet’s Drug Review Profile series looks at the unusual history of a systemic sclerosis interstitial lung disease indication for Genentech’s Actemra that was revived at the FDA’s behest and vetted by CDER’s high-level CDER policy council.
Testing of autologous therapy in clinical trial patients who previously received CAR-T cells requires special consideration in initial material testing and study design, US FDA says in a draft guidance that also addresses potential need for bridging therapy in the event of a manufacturing delay or failure.
The latest drug development news and highlights from our US FDA Performance Tracker.