ROZLYTREK (entrectinib)

ROZLYTREK (entrectinib)

SELF ADMINISTRATION-ORAL 

 Diagnosis considered for coverage: 

• NSCLC: Indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test
• Solid Tumors: indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that:
  • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation,
  • are metastatic or where surgical resection is likely to result in severe morbidity, and
  • have progressed following treatment or have no satisfactory alternative therapy.
  • This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials

Coverage Criteria:

For diagnosis of NSCLC:

• Diagnosis of metastatic non-small cell lung cancer (NSCLC); AND
• Patient has ROS1 rearrangement positive tumor(s)

For diagnosis of solid tumors:

• Diagnosis of solid tumors; AND
• Disease has neurotrophic tyrosine receptor kinase (NTRK) gene fusion (e.g., ETV6-NTRK3, TPM3-NTRK1, TPR-NTRK1, etc.) as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA); AND
• Disease is without a known acquired resistance mutation (e.g., TRKA G595R, TRKA G667C or TRKC G623R substitutions); AND
• Disease is one of the following:
  • Metastatic 
  • Unresectable (including cases where surgical resection is likely to result in severe morbidity); AND
• One of the following:
  • Disease has progressed following previous treatment (e.g., surgery, radiation therapy, or systemic therapy) 
  • Disease has no satisfactory alternative treatments

Reauthorization Criteria:

For diagnosis of NSCLC and solid tumors:

• Patient does not show evidence of progressive disease while on therapy

Dosing: 

NSCLC:

• 600 mg orally once daily until disease progression or unacceptable toxicity

Solid Tumors:

• Adults and pediatric patients with BSA ≥ 1.51 m²: 600 mg orally once daily until disease progression or unacceptable toxicity
• Pediatric patients > 6 months: 
  • 
• Pediatric patients > 1 month to ≤ 6 months: 250 mg/m² orally once daily until disease progression or unacceptable toxicity

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• The most common cancers listed in the pivotal trials which evaluated the efficacy of Rozlytrek were: sarcoma, lung, salivary gland tumors, breast, thyroid and colorectal cancer.
• Rozlytrek is available in two dosage forms, and can be administered either as capsules swallowed whole, capsules made into an oral suspension (or for enteral tube administration) and as oral pellets swallowed with soft food

Policy Updates:

• Effective 10/15/2019 – New policy approved by WHA P&T Committee. (P&T, 10/15/2019)
• Effective 6/1/2024 – Updated policy for NSCLC and solid tumors (P&T, 5/21/2024)

References:

1. Rozlytrek Prescribing Information. Genentech USA, Inc. South San Francisco, CA. October 2023. 
2. Drilon A, Nagasubramanian R, Blake JF, et al. A next-generation TRK kinase inhibitor overcomes acquired resistance to prior TRK kinase inhibition in patients with TRK fusion-positive solid tumors. Cancer Discov. 2017 Sep;7(9):963-972.