Takeda Pharmaceutical Voluntarily Withdraws Lung Cancer Therapy in the U.S.

Takeda Pharmaceutical, a leading Japanese pharmaceutical company, has announced its decision to voluntarily withdraw its lung cancer therapy from the United States. The therapy, known as Exkivity, had received accelerated approval in 2021 but failed to meet the main goal in a late-stage study. As a result, Takeda has decided to withdraw the therapy from the U.S. market.

The news of the therapy’s withdrawal caused a decline in Takeda’s U.S.-listed shares, which fell approximately 6% in extended trading. The failure to meet the study’s goal means that Exkivity 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.

Takeda had previously halted the study in July, citing futility and the unlikelihood of meeting its goal. The company also withdrew its application for marketing authorization in the European Union in 2022. The late-stage trial investigated the safety and efficacy of Exkivity as a monotherapy compared to a type of chemotherapy in patients with non-small cell lung cancer (NSCLC).

Takeda plans to present full data from the late-stage trial at an upcoming medical meeting or publish it in a peer-reviewed journal. The company also intends to initiate a voluntary withdrawal of Exkivity globally, where the therapy was approved, and is working with regulators in other countries to determine the next steps.

Although Exkivity had received approval in Switzerland, South Korea, Australia, and China, in addition to the United States, Takeda’s decision to withdraw the therapy globally will impact its availability in these countries as well.

The U.S. FDA had initially 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, on the other hand, 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 is currently assessing the impact of the therapy’s withdrawal and will update its annual forecast for the fiscal year ending March 31, 2024, accordingly.

In conclusion, Takeda Pharmaceutical’s voluntary withdrawal of its lung cancer therapy, Exkivity, from the United States is a significant development in the field of oncology. The company’s decision comes after the therapy failed to meet its main goal in a late-stage study. Takeda will continue to evaluate the impact of this withdrawal and adjust its financial forecast accordingly.