Exkivity FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 6, 2023.
FDA Approved: Yes (Discontinued) (First approved September 15, 2021)
Brand name: Exkivity
Generic name: mobocertinib
Dosage form: Capsules
Company: Takeda Pharmaceutical Company Limited
Treatment for: Non Small Cell Lung Cancer
Exkivity (mobocertinib) is an oral tyrosine kinase inhibitor for the treatment of patients with epidermal growth factor receptor (EGFR) exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC).
- Exkivity is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- EGFR regulates signaling pathways in the control of cellular proliferation, and EGFR mutations have been associated with NSCLC. Exkivity is the first and only approved oral therapy designed to specifically bind to and inhibit EGFR exon 20 insertion mutations
- Exkivity capsules are taken orally, once daily, with or without food.
- Exkivity can cause serious adverse reactions including interstitial lung disease (ILD)/pneumonitis, cardiac toxicity, and severe diarrhea. The Exkivity product label carries a boxed warning for QT (QTc) prolongation, including Torsades de Pointes, which can be life-threatening.
- Common side effects include diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, musculoskeletal pain, and laboratory abnormalities.
- On October 2, 2023, Takeda announced that, following discussions with the U.S. Food and Drug Administration (FDA), it would 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. 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.
Development timeline for Exkivity
Further information
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