Takeda Announces Voluntary Withdrawal of Mobocertinib (Exkivity), the First Oral Therapy Targeting EGFR Exon20 Insertion Mutations, Following Failed Phase 3 Trial

On October 2, 2023, the official website of Japan's Takeda Pharmaceutical Company announced that after discussions with the U.S. FDA, the company will collaborate with the FDA to voluntarily withdraw EXKIVITY® (mobocertinib) in the United States for adult patients with EGFR exon20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. Takeda intends to initiate a similar voluntary withdrawal globally where EXKIVITY is approved and is working with regulatory authorities in other countries to take the next steps. This decision is based on the results of the Phase 3 EXCLAIM-2 trial, which did not meet its primary endpoint and therefore did not fulfill the requirements for confirmatory evidence under the U.S. FDA’s accelerated approval or the conditional marketing authorization requirements in other countries.