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ASCO Data Could Clarify Ocular Toxicity Concerns For ImmunoGen’s Mirvetuximab

Pivotal Trial Results And Pooled Safety Analysis Being Presented

Executive Summary

ImmunoGen may need to mount an aggressive education campaign to get in front of issues like blurred vision and keratopathy, with ocular toxicity being common among antibody-drug conjugates.

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Patent Office Opposes Ruling On Ovarian Cancer Drug, Wants Stronger Obviousness Standard

After Federal Circuit vacates district court ruling that patent on method of dosing ImmunoGen’s mirvetuximab soravtansine is indefinite and obvious, PTO warns of ‘well-documented problem’ of drug manufacturers receiving follow-on patents for ‘trivial modifications’ that delay generics.

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.

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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