Takeda provides update on Exkivity (mobocertinib) for epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive NSCLC

Takeda announced that, following discussions with the FDA, it will be working with the FDA towards a voluntary withdrawal of Exkivity (mobocertinib) in the U.S. for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy. Takeda intends to similarly initiate voluntary withdrawal globally where Exkivity is approved and is working with regulators in other countries where it is currently available on next steps.

This decision was based on the outcome of the Phase III EXCLAIM-2 confirmatory trial, which did not meet its primary endpoint and thus did not fulfill the confirmatory data requirements of the Accelerated Approval granted by the U.S. FDA nor the conditional marketing approvals granted in other countries.