Takeda to pull Exkivity from US market

Follwing discussions with the US Food and Drug Administration (FDA), Japanese pharm major Takeda (TYO: 4502) said it will be working with the agency towards a voluntary withdrawal of Exkivity (mobocertinib) in the USA 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.

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 FDA nor the conditional marketing approvals granted in other countries. The FDA’s oncology department has lately taken a hard line on accelerated approval regulations.

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.