NEW YORK – Takeda on Tuesday said it will voluntarily withdraw approval of Exkivity (mobocertinib) in the US for the treatment of EGFR exon 20-mutant locally advanced or metastatic non-small cell lung cancer patients who progressed after chemotherapy.
The company is withdrawing the drug's accelerated approval after the Phase III EXCLAIM-2 confirmatory trial did not meet its primary endpoint of progression-free survival. The trial was evaluating Exkivity monotherapy versus platinum-based chemo as a first-line treatment for EGFR exon 20 insertion-positive locally advanced or metastatic NSCLC. The full results from EXCLAIM-2 will be presented at an upcoming medical meeting or published in a peer-reviewed journal, the company said.
Takeda also plans to initiate voluntary withdrawal globally where Exkivity is approved, including in the UK where it was approved last year. In July 2022, Takeda withdrew its application for conditional marketing authorization of Exkivity.
The drug was granted accelerated approval based on data from 114 untreated EGFR exon 20-mutant NSCLC patients in a Phase I/II trial. Results from this cohort of patients, presented in January 2021, demonstrated a median duration of response among these patients of 17.5 months and median progression-free survival of 7.3 months.