Japan-based Takeda (TYO: 4502) has announced the voluntary global withdrawal of its tyrosine kinase inhibitor (TKI) Exkivity (mobocertinib) from the U.S. market. This decision comes after a Phase III confirmatory trial failed to meet its primary efficacy endpoint. Exkivity, a first-in-class therapy, had previously received conditional approvals worldwide as a monotherapy for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) who experienced disease progression during or after platinum-containing chemotherapy and possess insertion mutations in EGFR exon 20.
No New Safety Concerns Identified
Despite the trial’s disappointing results, Takeda highlighted that no new safety signals were observed during the study. The company is committed to ensuring that patients can continue to receive Exkivity when it is deemed appropriate by healthcare professionals. This measure aims to support ongoing patient care while navigating the withdrawal process.
Global Presence of Exkivity
According to Fineline Info & Tech data, Exkivity is also registered in Brazil and China, indicating Takeda’s broader international footprint for this therapy. The withdrawal from the U.S. market marks a significant shift for the company as it reassesses its strategy for this product in light of recent clinical findings.-Fineline Info & Tech
