FDA approves Actemra for cytokine release syndrome

FDA approved a label expansion for IV Actemra tocilizumab to treat chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients ages two and older. The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said Actemra is the first FDA-approved treatment for that indication. Genentech submitted an sBLA in June seeking the label expansion, which FDA assessed under Priority Review.

The agency based its approval on retrospective analysis of pooled outcome data from 45 blood cancer patients treated with Actemra in clinical trials of CAR T cell therapies, which showed that 69% of patients achieved resolution of CRS within 14 days after the first dose of Actemra. The analysis included data from the registrational Phase II ELIANA trial of Kymriah tisagenlecleucel (CTL019) from Novartis AG (NYSE:NVS; SIX:NOVN) in pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL). ...