Takeda to Voluntarily Withdraw Exkivity Following Talks with FDA

By Denny Jacob

Takeda Pharmaceutical plans to voluntarily withdraw exkivity following discussions with the Food and Drug Administration.

The company, which develops and manufactures pharmaceutical drugs, said it intends to similarly initiate voluntary withdrawals where the treatment is approved and is working with regulators in other countries where it is available on next steps.

The decision to withdraw was based on the outcome of a Phase 3 trial that didn't meet its primary endpoint, didn't fulfill confirmatory data requirements of the accelerated approval granted by the FDA or the conditional marketing approvals granted in other countries, Takeda said.

The withdrawal of exkivity in the U.S. is 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.

Takeda said it will continue to assess the impact of its withdrawal and will update its outlook for the fiscal year ending March 31 if necessary.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

October 02, 2023 17:01 ET (21:01 GMT)

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