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ROZLYTREK indication1

ROZLYTREK as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older, with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, 

  • Who have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and
  • Who have not received a prior NTRK inhibitor
  • Who have no satisfactory treatment options.

ROZLYTREK as monotherapy is also indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for details on how to report adverse reactions. 

Watch the video to find out more about the ROZLYTREK clinical trial data

ROZLYTREK is a potent, selective ROS1 and TRK inhibitor demonstrating antitumour activity within the CNS1–3

ROZLYTREK was designed to remain and deliver benefit in the CNS.1,4

ROZLYTREK is a weak substrate of P-gp and therefore is able to achieve clinically meaningful concentrations in the CNS.1,3,5

ROZLYTREK is the first and only approved agent to deliver a meaningful response with intracranial efficacy in ROS1+ NSCLC1

In ROS1+ NSCLC:

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ROZLYTREK delivered a clinically meaningful ORR of 67.1%1

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ROZLYTREK delivered a median PFS of almost 16 months, with a 12-month survival rate of 81%1,2

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ROZLYTREK delivered an intracranial response in almost 80% of patients with measurable CNS metastases at baseline, with responses maintained for at least 12 months in over half of these1

In ROS1+ advanced NSCLC, up to 40% of patients have CNS metastases at diagnosis.6

ROZLYTREK delivers clinically meaningful responses in NTRK fusion+ solid tumours, irrespective of baseline CNS metastases1,7

In NTRK fusion+ solid tumours:

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ROZLYTREK delivered a clinically meaningful ORR of 63.5%1

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ROZLYTREK delivered 11.2 months PFS, with nearly
2 years overall survival7 

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ROZLYTREK delivered an intracranial ORR of 62.5%,*1 and high rates of CNS disease progression-free time8

NTRK is emerging as an actionable biomarker and oncogenic driver across a wide range of tumour types,9–16 with NTRK fusions identified in at least 25 tumour types in adult and paediatric patients9–11, 14–16

ROZLYTREK was well tolerated in clinical trials, with the majority of adverse events manageable7

  • Most adverse events were of grade 1 or 2
  • 27.0% of patients required dose interruption due to TRAEs
  • 24.6% of patients required dose reduction due to TRAEs
  • Permanent discontinuation of ROZLYTREK due to a TRAE occurred in 4.6% of patients.

ROZLYTREK offers convenient dosing1

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Adults: Recommended dose is 600 mg orally once-daily.
Children: Recommended dose for paediatric patients aged 12 years and older is 300 mg/m2 orally once-daily for those who can swallow whole capsules.

  • For paediatric patients with body surface area of 1.11 m2 - 1.50 m2, recommended dose is 400 mg once-daily
  • For paediatric patients with body surface area of ≥1.51 m2, recommended dose is 600 mg once-daily
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Can be taken with or without food.

More information about ROZLYTREK is coming soon. To find out more about ROZLYTREK please contact your local Roche representative >

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for details on how to report adverse reactions. 

Footnotes

*In patients with measurable CNS metastases.

CNS, central nervous system; NSCLC, non-small cell lung cancer; NTRK, neurotrophic tropomyosin receptor kinase; ORR, overall response rate; PFS, progression-free survival; P-gp, P-glycoprotein; ROS1, c-ros oncogene 1; TRAE, treatment-related adverse event; TRK, tyrosine kinase.

References

  1. ROZLYTREK® Summary of Product Characteristics, F, Hoffman-La Roche, 2020.
  2. Krebs MG, et al. Efficacy and safety of entrectinib in locally advanced/metastatic ROS1 fusion-positive NSCLC: an updated integrated analysis. Poster 1287P.
  3. Deeken JF, Löscher W. Clin Cancer Res 2007;13:1663–1674.
  4. Drilon A, et al. Lancet Oncol 2020;21:261–270.
  5. Fischer H, et al. Neuro Oncol 2020;22:819–829.
  6. Patil T, et al. J Thorac Oncol 2018;13:1717–1726. 
  7. Patel M, et al. Ann Oncol 2020;31(Suppl 3):232–233.
  8. Rolfo C, et al. Efficacy and safety of entrectinib in patients with NTRK Fusion-Positive (NTRK-fp) solid tumours: an updated integrated analysis. Poster P335.
  9. Vaishnavi A, Le AT, Doebele RC. Cancer Discov 2015;5:25–34. 
  10.  Lange AM, Lo HW. Cancers (Basel) 2018;10.
  11.  Amatu A, Sartore-Bianchi A, Siena S. ESMO Open 2016;1:e000023. 
  12.  Khotskaya YB, et al. Pharmacol Ther. 2017;173:58–66. 
  13.  de Lartigue J. TRK inhibitors advance rapidly in “tumor-agnostic” paradigm. OncologyLive. 2017;18. Available at: https://www.onclive.com/publications/oncology-live/2017/vol-18-no-15/trk-inhibitors-advance-rapidly-in-tumoragnostic-paradigm (Accessed August 2020). 
  14. Dupain C, et al. Mol Ther Nucleic Acids 2017;6:315–326. 
  15.  Kummar S, Lassen UN. Target Oncol 2018;13:545–556. 
  16.  Cocco E, Scaltriti M, Drilon A. Nat Rev Clin Oncl 2018;15:731–747.