(Reuters) – Takeda Pharmaceutical said on Monday it would be working with the U.S. health regulator towards a voluntary withdrawal of its lung cancer therapy in the country, after it failed to meet the main goal in a late-stage study.
The late-stage trial studied the safety and efficacy of Exkivity as a monotherapy versus a type of chemotherapy in patients with non-small cell lung cancer.
The therapy thus does not fulfill the confirmatory data requirements of the accelerated approval granted by the U.S. Food and Drug Administration nor the conditional marketing approvals granted in other countries, the Japan-based company said.
Takeda intends to similarly initiate voluntary withdrawal globally where the therapy is approved and is working with regulators in other countries where it is currently available on next steps.
The U.S. FDA had approved Exkivity in 2021 for patients with a specific gene mutation called EGFR Exon20 insertions in non-small cell lung cancer, whose disease has progressed on or after chemotherapy, based on results from an early- to mid-stage trial.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)
