FDA/Panel Decisions

Affimed Announces RMAT Designation To Combination Therapy Of ICE Acimtamig And AB101

Affimed N.V. (AFMD) announced the FDA has granted RMAT designation to the combination therapy of Affimeds innate cell engager acimtamig and Artiva Biotherapeutics AlloNK or AB101 for the treatment of relapsed or refractory Hodgkin Lymphoma. The designation provides Affimed enhanced access to FDA resources including the potential for accelerated approval and priority review.

The combination is being evaluated in the LuminICE-203 multicenter, multi-cohort phase 2 trial. Earlier in the year, Affimed reported promising early efficacy data from
cohorts 1 and 2 of the LuminICE-203 trial.

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by RTTNews Staff Writer

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