ImmunoGen Needs Another Phase III For Its ADC In Ovarian Cancer
The biotech’s hopes for an accelerated approval on subgroup data were dashed by the US FDA, but it will work with the agency to design a Phase III focused on highly FRα-positive patients.
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Keeping Track: Novel Oncologics Submitted By Taiho, ImmunoGen, Y-mAbs; US FDA Declines Akebia’s Vadadustat
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ImmunoGen’s Mirvetuximab Confidence Justified With Ovarian Cancer Win
The response rate, with five complete responses, exceeds known responses to standard-of-care chemotherapy in heavily pre-treated folate receptor alpha-high patients. A US FDA filing is on track for early 2022.