ImmunoGen submits biologics license application to the US Food and Drug Administration for mirvetuximab soravtansine in ovarian cancer

ImmunoGen

29 March 2022 - Submission based on positive results from pivotal Phase 3 SORAYA trial.

ImmunoGen today announced that it has submitted a biologics license application under the accelerated approval pathway to the U.S. FDA for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments.

Read ImmunoGen press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier