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The FDAs concerns go beyond simply the absence of trials

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Why this trial matters : First oral SERD to succeed in Phase III in early breast cancer Signals a potential new adjuvant standard of care Advances endocrine therapy beyond legacy agents Johnson & Johnson Tecvayli + Darzalex Faspro Shows Unprecedented Phase III Success in Relapsed/Refractory Multiple Myeloma The Phase III MajesTEC-3 trial demonstrated that the combination of Tecvayli (teclistamab) plus Darzalex Faspro (daratumumab SC) significantly improved progression-free survival and overall survival versus standard regimens in patients with relapsed/refractory multiple myeloma as early as second-line, with an ~83% reduction in disease progression or death at almost three years follow-up