Mersana slapped with partial FDA hold after five patient deaths in ovarian cancer studies

An­oth­er one of Mer­sana’s clin­i­cal pro­grams is re­port­ing pa­tient deaths in a study, and now it’s prompt­ing the FDA to step in.

The agency slapped Mer­sana with a par­tial clin­i­cal hold, the biotech an­nounced Thurs­day, halt­ing en­roll­ment in two of three stud­ies for the ovar­i­an can­cer ther­a­py up­i­fi­ta­m­ab ril­sodotin. In­ves­ti­ga­tors ob­served five fa­tal bleed­ing events from 560 pa­tients across all three stud­ies, prompt­ing the hold.

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