Takeda announces voluntary withdrawal of lung cancer therapy

[October 03, 2023]  (Reuters) -Japan's Takeda Pharmaceutical said on Monday it will voluntarily withdraw its lung cancer therapy from the United States, where it had received an accelerated approval in 2021, after it failed to meet the main goal in a late-stage study.

U.S.-listed shares of the company fell about 6% to $14.39 in extended trading as the failed study meant the therapy did not fulfill the confirmatory data requirements of the U.S. Food and Drug Administration's accelerated approval nor the conditional marketing approvals granted in other countries.

In July, Takeda had said the study had been halted due to futility as it was unlikely to meet its goal. It also withdrew its application for marketing authorization in the European Union in 2022.

The late-stage trial studied the safety and efficacy of Takeda's Exkivity as a monotherapy versus a type of chemotherapy in patients with non-small cell lung cancer (NSCLC).

Full data from the late-stage trial will be presented at an upcoming medical meeting or published in a peer-review journal, the company said.

Takeda also intends to initiate voluntary withdrawal globally where the therapy was approved and is working with regulators in other countries where it was available on the next steps.

Takeda Pharmaceutical Co's logo is seen at its new headquarters in Tokyo, Japan, July 2, 2018. REUTERS/Kim Kyung-Hoon/File Photo

The therapy was approved in Switzerland, South Korea, Australia and China, besides the United States.

The U.S. FDA had approved Exkivity for NSCLC patients with a specific gene mutation called EGFR Exon20 insertions whose disease had progressed on or after chemotherapy, based on results from an early- to mid-stage trial.

Johnson & Johnson is expecting its combination therapy of antibody treatment Rybrevant and experimental drug lazertinib to become a first-line treatment for NSCLC patients with the mutation.

Takeda said on Monday it will continue to assess the impact of the withdrawal and update its annual forecast for the fiscal year ending March 31, 2024.

(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar and Shinjini Ganguli)

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