FDA be­stows ac­cel­er­at­ed ap­proval on Im­muno­Gen's ovar­i­an can­cer drug, with con­fir­ma­to­ry an­swer com­ing soon

Three and a half years ago, Im­muno­Gen ran up against an FDA brick wall. Its ovar­i­an can­cer drug, mirve­tux­imab so­rav­tan­sine, failed a Phase III study, forc­ing the biotech to scale back and lay off more than two-thirds of its staff. Ex­ecs tight­ened their belts to pre­serve the cash they had left.

And Mon­day, af­ter shep­herd­ing the pro­gram through an­oth­er piv­otal tri­al, the move ap­peared to pay off.

The FDA ap­proved Im­muno­Gen’s drug Mon­day af­ter­noon, cap­ping the turn­around af­ter the biotech slashed its staff from about 300 to 80. The an­ti­body-drug con­ju­gate, which will be brand­ed as Ela­here, is the US’ first new treat­ment for ad­vanced ovar­i­an can­cer in at least sev­en years. Ela­here comes with a black box warn­ing for oc­u­lar tox­i­c­i­ty.

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