Takeda announces FDA approval for EXKIVITY™ (mobocertinib)

Takeda has announced that the US Food and Drug Administration (FDA) has approved EXKIVITY™ (mobocertinib), the first oral therapy to target epidermal growth factor receptor (EGFR) exon 20 insertion mutations in metastatic non-small cell lung cancer (NSCLC).1

EXKIVITY is a kinase inhibitor 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).1

EGFR exon 20 insertion-positive NSCLC is a rare subtype of NSCLC.2 EXKIVITY is a tyrosine kinase inhibitor developed to inhibit EGFR exon 20 insertion mutations.1

The most common (>20%) adverse reactions were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased amylase, increased lipase, decreased potassium, decreased hemoglobin, increased creatinine, and decreased magnesium.1

Please see full Prescribing Information, including Boxed Warning.

To learn more about EXKIVITY, please visit EXKIVITYhcp.com.

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