Drug updated on 3/28/2024
| Dosage Form | Capsule (oral; 40 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Summary
- Mobocertinib (Exkivity) is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.
- Two systematic reviews/meta-analyses were reviewed to gather information about Exkivity's effectiveness and safety profile in treating NSCLC patients harboring EGFR exon 20 insertions who had previously received platinum-based chemotherapy.
- According to one review, mobocertinib was identified as one of the most promising treatments based on efficacy data. However, gastrointestinal and dermatological adverse reactions were noted as relevant side effects associated with this drug regimen.
- The same review also highlighted that all clinical trials assessing these therapies presented a non-randomized design which limits the quality of evidence available. Therefore, comparative studies involving larger sample sizes are needed to reliably quantify the effect of these drugs including mobocertinib.
- Another systematic literature review found that conventional treatments used in patients with EGFR exon 20 insertion mutation-positive NSCLC have limited efficacy compared to new targeted treatments like mobocertinib. This suggests that identifying EGFR exon 20 insertion mutations could be crucial for improving therapeutic options for these patients.
- While there is limited real-world evidence available for recently approved agents like mobocertinib targeting exon 20 insertions specifically, interventional evidence supports their potential as effective treatment options according to this second meta-analysis document.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Exkivity (mobocertinib) Prescribing Information. | 2023 | Takeda Pharmaceuticals America Inc., Lexington, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| New therapies in non-small cell lung cancer with EGFR exon 20 insertion mutations. | 2023 | Journal of Oncology Pharmacy Practice |
| Non-small cell lung cancer with EGFR exon 20 insertion mutation: a systematic literature review and meta-analysis of patient outcomes. | 2022 | Current Medical Research and Opinion |