Takeda Withdraws Lung Cancer Drug From US After Failed Confirmatory Trial

Following discussions with the FDA, Takeda Pharmaceutical Co Ltd TAK will voluntarily withdraw Exkivity (mobocertinib) in the U.S. 

Exkivity is indicated 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 the next steps.

The decision was based on the outcome of the Phase 3 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 EXCLAIM-2 Phase 3 trial was designed to investigate the safety and efficacy of Exkivity as monotherapy versus platinum-based chemotherapy in first-line EGFR Exon20 insertion+ locally advanced or metastatic NSCLC. 

Takeda will continue to assess the impact of the withdrawal and update the full-year, consolidated forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023), as appropriate and necessary.

In July, Takeda voluntarily withdrew its marketing application for its dengue vaccine, TAK-003 candidate, following discussions with the FDA, citing data collection issues, which cannot be addressed within the current review cycle.

Price Action: TAK shares are down 2.09% at $14.56 during the premarket session on the last check Tuesday.