Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant
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