After a disappointing data readout from the Phase III FORWARD 1 study of its antibody-drug conjugate (ADC) mirvetuximab soravtansine in ovarian cancer, ImmunoGen Inc. tried to placate investors with plans to seek an accelerated approval based on overall survival data in a patient subgroup. The company’s stock rebounded somewhat on that strategy, but fell again on 15 May when the Boston-area firm said the FDA declined to consider an accelerated approval.
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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