Takeda Pharmaceuticals, a Japan-based drugmaker, is voluntarily withdrawing Exkivity (mobocertinib) in the U.S. after a phase 3 trial failed to confirm the lung cancer drug's efficacy.
The trial enrolled about 300 patients to assess progression free survival rates, overall survival, duration of response and side effects. The study did not find any new safety issues, Takeda said in an Oct. 2 news release, nor did it meet the FDA's benchmark for confirmatory trials among accelerated approval products.
In 2021, the FDA granted the drug accelerated approval for adult patients with epidermal growth factor receptor Exon20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy, according to the release.
Takeda said it is working with regulators in other countries to determine "next steps."