Exkivity™
Drug - Exkivity™ (mobocertinib) [Takeda Pharmaceuticals America, Inc.]
April 2022
Therapeutic area - Oncology, Oral - Lung
Initial approval criteria
- Patient must be at least 18 years old AND
Universal Criteria
- Patient does not have untreated brain metastases (clinically stable asymptomatic brain metastases are allowed) AND
- Patient does not have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis AND
- Left ventricular ejection fraction (LVEF) is measured prior to initiating therapy and will be assessed at regular intervals during treatment AND
- Patient does not have prolonged QTc interval, or is currently being treated with medications known to be associated with the development of Torsades de Pointes AND
- Exkivity will not be used in combination with amivantamab AND
- Patient will avoid concomitant therapy with any of the following:
- Coadministration with drugs that prolong the QTc interval, if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented AND
- Coadministration with strong or moderate CYP3A4 inhibitors (e.g., fluconazole, itraconazole, etc.), if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented AND
- Coadministration with strong and moderate CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s Wort, etc.) AND
Non-Small Cell Lung Cancer (NSCLC)
- Exkivity will be used as single agent therapy AND
- Patient has locally advanced or metastatic disease AND
- Patient disease has epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved or CLIA compliant test AND
- Patient has disease progression on or subsequent to platinum-based chemotherapy
Renewal criteria
- Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III AND
- Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: interstitial lung disease (ILD)/pneumonitis, cardiac toxicity (grade ≥2 decreased ejection fraction or heart failure, QT interval prolongation), severe diarrhea, etc.
Quantity limits
Background
Exkivity is a kinase inhibitor 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, 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).
Questions?
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