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# FDA Withdraws Takeda NDA for Exkivity
- URL: https://www.fdaweb.com/fda-withdraws-takeda-nda-for-exkivity/
- Published: 2024-07-12T12:00:00.000Z
- Updated: 2026-09-14T14:35:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157337

*Federal Register* notice: FDA is withdrawing approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after the company requested the action in response to a confirmatory study failing to demonstrate the therapy’s clinical benefit. The drug was granted accelerated approval 9/2021 for treating adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. To view the notice click [here](https://public-inspection.federalregister.gov/2024-15371.pdf?ref=fdaweb.com).