Takeda Initiates Voluntary Withdrawal of EXKIVITY Following Trial Outcomes

by Sinead Huang
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In a significant announcement, Takeda revealed its decision to voluntarily withdraw EXKIVITY (mobocertinib) in the U.S. for patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (NSCLC). 

This decision came after discussions with the U.S. Food and Drug Administration (FDA) and was based on the results of the Phase 3 EXCLAIM-2 confirmatory trial. The trial did not meet its primary endpoint, preventing EXKIVITY from fulfilling the requirements of its Accelerated Approval by the FDA and conditional marketing approvals in other countries. The EXCLAIM-2 trial, designed to assess the safety and efficacy of EXKIVITY as a monotherapy, did not show the desired outcomes, leading to this voluntary withdrawal.

Related article: FDA Expands Approval For Takeda’s Takhzyro To Prevent Hereditary Angioedema Attacks

Ensuring Patient Access and Exploring Future Research Avenues

Takeda, a pharmaceutical company dedicated to addressing high unmet medical needs, expressed its ongoing commitment to patients and the scientific community. Patients currently undergoing treatment with EXKIVITY are encouraged to consult their healthcare providers, and Takeda is actively collaborating with regulatory authorities to ensure continued access for these patients. The company’s steadfast dedication to underserved populations remains undeterred, with a focus on advancing research and development to find solutions for solid tumors and hematologic cancers. While the withdrawal marks a setback, Takeda’s dedication to improving patient outcomes remains resolute.

EXKIVITY’s Role in EGFR Exon20 Insertion+ NSCLC and Ongoing Medical Research

EXKIVITY, a groundbreaking oral tyrosine kinase inhibitor (TKI), was specifically tailored to target EGFR Exon20 insertion mutations. The approval of EXKIVITY was a beacon of hope for patients who had limited treatment options. Despite the withdrawal, Takeda emphasized the impact EXKIVITY had on this patient group and expressed hope that insights gained from the EXCLAIM-2 study would pave the way for future research and development. The dedication to finding transformative medicines for patients with high unmet needs continues to drive Takeda’s scientific pursuits.

Takeda’s decision regarding EXKIVITY underscores the complexities of drug development and the challenges in addressing specific genetic mutations. While the withdrawal is a setback, Takeda’s enduring commitment to patient care, access, and scientific innovation remains unwavering. The company continues to explore avenues for research, hoping to usher in a new era of treatments for solid tumors and hematologic cancers. As the medical landscape evolves, Takeda stands firm in its mission to improve the lives of patients and make significant strides in the field of oncology.

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