FDA ax­es di­ag­nos­tic re­quire­ment for Lil­ly's Verzenio + en­docrine ther­a­py in cer­tain breast can­cer pa­tients

In the fall of 2021, when the FDA first au­tho­rized Eli Lil­ly’s CD4/6 in­hibitor Verzenio plus en­docrine ther­a­py in ear­ly-stage HR-pos­i­tive, HER2-neg­a­tive breast can­cer and at high risk of re­cur­rence, the drug gi­ant was lim­it­ed in that pa­tients had to have a Ki-67 score — a di­ag­nos­tic test and stain­ing tech­nique that has been cor­re­lat­ed to a worse prog­no­sis in breast can­cer pa­tients — of at least 20%.

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