ROZLYTREK (entrectinib)

ROZLYTREK (entrectinib)

SELF ADMINISTRATION-ORAL 

 Indications for Prior Authorization: 

• Adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
• Adult and pediatric patients 12 years of age and older with solid tumors that:
  • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation.
  • are metastatic or where surgical resection is likely to result in severe morbidity,
  • have progressed following treatment or have no satisfactory alternative therapy.

Patients must meet the following Criteria for the indications above:

• Prescribed by or in collaboration with an oncologist; AND
• Patient is ≥ 18 years of age with metastatic NSCLC whose tumors are ROS1-positive.
  • AND provide documentation with ROS1-positive testing.

OR

• Patient is ≥ 12 years of age with solid tumors that:
  • The patient’s tumor has a NTRK gene fusion without a known acquired resistance mutation (confirmed by chart note documentation);  AND
  •  Patient’s tumor is metastatic OR where surgical resection is likely to result in severe morbidity; AND
  •  Have progressed following treatment OR have no satisfactory alternative therapy

Dosing: 

• ROS1-Positive Non-Small Cell Lung Cancer: 

  • 600 mg orally once daily.

• NTRK Gene Fusion-Positive Solid Tumors: 

  •  Adults: 600 mg orally once daily

• Pediatric Patients 12 Years and Older with solid tumor: Recommended dosing based on body surface area (BSA) as shown below:

  •  BSA greater than 1.50 m² : 600 mg once daily
  •  BSA 1.11 to 1.50 m² : 500 mg once daily
  •  BSA 0.91 to 1.10 m² : 400 mg once daily

Approval: 

•  1 year