Takeda Provides Update on EXKIVITY® (mobocertinib)

Takeda has announced that following discussions with the U.S. Food and Drug Administration (FDA), we will begin the process of voluntarily withdrawing EXKIVITY (mobocertinib) from the U.S. market over the next few months. EXKIVITY is currently indicated for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. For the U.S. Prescribing Information, including the Boxed Warning, please visit www.exkivity-update.com/prescribing-information.

This decision to voluntarily withdraw EXKIVITY 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. 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 mNSCLC. No new safety signals were observed in the EXCLAIM-2 trial. Full data from the trial will be presented at an upcoming medical meeting and published in a peer-reviewed journal.

EXKIVITY remains available to prescribe while Takeda works with the FDA on withdrawal timing. Takeda will provide updates as appropriate to keep you informed. Updates will also be posted on www.exkivity-update.com. Takeda has shared a similar communication with healthcare providers that have prescribed EXKIVITY.

Takeda is committed to ensuring that patients receiving EXKIVITY can maintain access when EXKIVTIY is withdrawn. For additional questions, please contact Takeda at 844-662-8532 or globaloncologymedinfo@takeda.com.

No comments have been posted yet.