Roche Seeks Speedy EU Review For Second Bispecific Antibody
The European Medicines Agency was this week deciding whether to grant accelerated assessment for glofitamab.
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If Roche gets the nod from the European Medicines Agency for mosunetuzumab this week, it could become the first company to market a CD20xCD3 bispecific antibody for follicular lymphoma.
MEI/Kyowa Kirin will no longer seek accelerated approval based on a single-arm study as the FDA is calling for Phase III data due to growing conservatism regarding the PI3K class.