Tabrecta™
Drug - Tabrecta™ (capmatinib) [Novartis Pharmaceuticals Corporation]
September 2020
Therapeutic Area - Oncology, Oral─Non-small Cell Lung Cancer
Initial approval criteria
- Patient is ≥ 18 years old AND
- Patient has diagnosis of metastatic or advanced non-small cell lung cancer (NSCLC) AND
- Patient’s disease has a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test AND
- Patient’s disease is epidermal growth factor receptor (EGFR) wild-type, as identified by a validated test AND
- Patient’s disease does NOT contain an anaplastic lymphoma kinase (ALK)-rearrangement, as identified by a validated test AND
- Patient does not have symptomatic CNS metastases AND
- Patient has not previously failed treatment with cMET or HGF -inhibitors (e.g., crizotinib) AND
- Capmatinib will be used as a single agent AND
- Patient will avoid coadministration with strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s wort)
- Initial approval is for 6 months
Renewal criteria
- Patient must continue to meet the above initial criteria AND
- Patient has disease response with treatment, as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
- Patient has NOT experienced any treatment-restricting adverse effects (e.g., severe hepatotoxicity, interstitial lung disease/pneumonitis, severe photosensitivity)
- Renewal approval is for 6 months
Quantity limits
Background
Tabrecta is FDA-approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. 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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