Breaking News, Trials & Filings

FDA Accepts Novartis’ sBLA for Priority Review

For a new CAR-T cell therapy treatment

The FDA has accepted the Priority Review of Novartis’ supplemental Biologics License Application (sBLA) for Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019. It’s for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT).    In addition, the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Author...

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