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    Rozlytrek™

    Drug - Rozlytrek™ (entrectinib) [Genentech Inc.]

    February 2020

    Therapeutic area - Oncology, Oral - Lung

    Initial approval criteria

    • Patient meets disease state-specific criteria described below AND
    • Patient does not have a history of prolonged QTc interval (e.g., QTc interval > 450 milliseconds) AND
    • Patient will not use therapy in combination with drugs which prolong QT-interval (e.g., amiodarone, sotalol, levofloxacin, venlafaxine, quetiapine, sumatriptan) AND
    • Patients with symptoms of or known risk factors for congestive heart failure have had left ventricular ejection fraction assessed prior to therapy AND
    • Patient will not use therapy with other NTRK-inhibitor therapy or ROS1-directed therapy (e.g., crizotinib, larotrectinib) AND
    • Patient does not have signs and symptoms of hyperuricemia as evidenced by a baseline serum acid level as tested prior to initiation of therapy AND
    • Baseline serum acid level is provided at time of request AND
    • Patient will avoid concomitant use with moderate or strong CYP3A inducers (e.g., rifampin,carbamazepine, St. John’s Wort) AND
    • Patient will avoid concomitant use with moderate or strong CYP3A inhibitors (e.g., erythromycin, itraconazole, indinavir, grape fruit juice). If avoidance is not possible, Rozlytrek dose will be decreased.

    Disease State-Specific Criteria (patient meets criteria described below for either solid tumors with neurotrophic receptor tyrosine kinase [NTRK] gene fusion or non-small cell lung cancer [NSCLC])

    • Solid Tumors with NTRK gene fusion
      • Patient is ≥ 12 years old AND
      • Patient has 1 of the following solid tumors: soft tissue sarcoma, salivary gland (mammary analogue secretory carcinoma), NSCLC, or breast cancer* AND
      • Tumor has an NTRK gene fusion or fusion partner in ETV6-NTRK3 or TPM3-NTRK1 or TPR-NTRK1†without a known acquired resistance mutation AND
      • Patient has metastatic disease or locally advanced disease and is not a candidate for surgery due to the potential  of causing severe morbidity AND
      • Patient has no satisfactory alternative treatments or disease has progressed following treatment AND
      • Patient has not received an NTRK-inhibitor in a previous line of therapy
    • Non-Small Cell Lung Cancer (NSCLC)
      • Patient is ≥ 18 years old AND
      • Patient has metastatic disease AND
      • Patient’s tumor is ROS1-positive‡ AND
      • Patient has not been previously treated with ROS1-inhibitor therapy (e.g., crizotinib, ceritinib, etc.)
    • Initial approval is for 6 months

    * Other tumors will be evaluated on a case-by-case basis.

    †An FDA-approved test for the detection of NTRK gene fusion is not currently available. NTRK gene fusions can be identified by means of the following testing methodologies: next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), or reverse transcription-polymerase chain reactions (RT-PCR), etc.

    ‡An FDA-approved test for the detection of ROS1 gene fusions is not currently available. ROS1 gene fusions can be identified by means of the following testing methodologies: NGS, FISH, etc.

    Renewal criteria

    • Patient must continue to meet the above criteria AND
    • There is documented disease response with treatment, as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
    • There is absence of unacceptable toxicity from the drug (e.g., congestive heart failure, hepatotoxicity, central nervous system effects [e.g., cognitive impairment, mood disorders, dizziness, sleep disturbances], skeletal fractures, hyperuricemia, QT-interval prolongation, visual disturbances)
    • Renewal approval is for 6 months

    Quantity limits

    Maximum dose of 600 mg/day; 30-day supply

    • 100 mg capsule: 150 capsules per 30 days
    • 200 mg capsule: 90 capsules per 30 days
    • Patient’s body surface area (BSA) must be provided at time of request for pediatric patients 12 years of age through 17 years of age

    Questions

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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