Takeda to voluntary withdraw lung cancer therapy Exkivity
Osaka: Takeda has announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will be working with the FDA towards a voluntary withdrawal of EXKIVITY (mobocertinib) in the U.S. for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy. Takeda intends to similarly initiate voluntary withdrawal globally where EXKIVITY is approved and is working with regulators in other countries where it is currently available on next steps.
This decision was based on the outcome of the Phase 3 EXCLAIM-2 confirmatory trial, which did not meet its primary endpoint and thus did not fulfill the confirmatory data requirements of the Accelerated Approval granted by the U.S. FDA nor the conditional marketing approvals granted in other countries.
The EXCLAIM-2 trial was a Phase 3, multicenter, open-label study designed to investigate the safety and efficacy of EXKIVITY as a monotherapy versus platinum-based chemotherapy in first-line EGFR Exon20 insertion+ locally advanced or metastatic NSCLC. No new safety signals were observed in the EXCLAIM-2 trial. Full data from the trial will be presented at an upcoming medical meeting or published in a peer-reviewed journal.
“Our steadfast commitment to pursue solutions for people with high unmet needs led us to develop and launch EXKIVITY as the first oral therapy designed for patients with EGFR Exon20 insertion+ metastatic NSCLC,” said Awny Farajallah, MD, head of Global Medical Affairs Oncology at Takeda. “We have been fortunate to witness the impact EXKIVITY has had on this previously underserved population and are encouraged to see the advancements made since its approval to introduce new therapies for these patients. We hope that findings from the EXCLAIM-2 study will inform future research and development for this disease.”
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EXKIVITY is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations.
