TAK - Takeda to voluntarily pull lung cancer drug Exkivity from U.S. market

2023-10-02 17:08:28 ET

Japanese pharmaceutical giant Takeda ( NYSE: TAK ) on Monday said it would voluntarily withdraw its lung cancer drug Exkivity from the U.S. market.

U.S.-listed shares of TAK were down 4.9% to $14.53 after hours.

The U.S. Food and Drug Administration (FDA) had approved Exkivity back in September 2021 for patients with a specific gene mutation called EGFR Exon20 insertion in non-small cell lung cancer, whose disease has progressed on or after platinum-based chemotherapy.

Takeda ( TAK ) said it was similarly planning to start voluntary withdrawal proceedings globally where the drug is approved, and is working with regulators in other countries where it is currently available on next steps.

The decision to withdraw the drug was based on the outcome of a late-stage confirmatory study called EXCLAIM-2, which did not meet its main goal, TAK said.

Takeda ( TAK ) had announced the stoppage of the trial in its quarterly results in July, saying at that time that the study had been halted for futility.

"We hope that findings from the EXCLAIM-2 study will inform future research and development for this disease," Awny Farajallah, head of global medical Affairs oncology at Takeda ( TAK ), said in a statement.

As per TAK's Q1 2023 results, sales of Exkivity more than tripled Y/Y to ¥2.1B (~$14M).

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