CPO301 receives fast track designation from the US FDA

CSPC Pharmaceutical

8 October 2024 - The board of directors of CSPC Pharmaceutical Group is pleased to announce that CPO301, a first in class antibody drug conjugate developed by the Group, has received fast track designation from the US FDA for the treatment of patients with recurrent or metastatic squamous non-small cell lung cancer with epidermal growth factor receptor (EGFR) over-expression that has progressed on or after treatment with platinum-based chemotherapy and anti-PD-(L1) therapy.

This is the second fast track designation granted by the US FDA for CPO301. The first fast track designation was granted for the treatment of patients with metastatic non-small cell lung cancer harbouring EGFR mutations who are relapsed/refractory to or ineligible for EGFR targeting therapy such as third generation EGFR inhibitors including osimertinib mesylate.

Read CSPC Pharmaceutical press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Fast track