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Thoughts on Gilead’s sBLA Submission for Yescarta in r/r iNHL (ZUMA-5)
On Friday, September 4, Gilead announced (press release) the submission of an sBLA to the FDA for Yescarta in r/r ≥3L iNHL (follicular lymphoma and marginal zone lymphoma). The sBLA application is based upon positive results from the Ph2 ZUMA-5 trial. Below, Celltelligence provides insights on Yescarta’s sBLA timeline and the potential impact from competitors Novartis (Kymriah) and BMS (liso-cel).