ImmunoGen looks to next Phase III after FDA rebuffs accelerated approval path for mirvetuximab

ImmunoGen plans to start a second Phase III trial before year end of mirvetuximab soravtansine that will focus on ovarian cancer patients with high FOLR1 expression after FDA told the company that data from a subgroup of those patients in the Phase III FORWARD I trial are not sufficient to support accelerated approval of the ADC as a single agent.

The setback sent shares of ImmunoGen Inc. (NASDAQ:IMGN) down $1.01 (32%) to $2.14 on Wednesday...