US FDA Approves Unique Mesothelioma Drug

A ‘first-of-its-kind’ cancer drug, manufactured by Bayer, was approved by the US Food and Drug Administration (FDA) in November 2018 for use in patients with different types of cancer, including mesothelioma.[1]

Larotrectinib, sold under the brand name VITRAVKI®,[2] is a tyrosine kinase (TRK) inhibitor, which is the only approved drug in circulation designed to target neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

This genomic alteration occurs during malignant mesothelioma development and the development of:

  • Salivary gland cancer;
  • Thyroid cancer;
  • Lung cancer;
  • Colon cancer;
  • Melanoma;
  • Gastrointestinal stromal tumours (GIST);
  • Infantile fibrosarcoma; and
  • Soft tissue sarcoma.

NTRK gene fusion can be diagnosed using specific tests, including next-generation sequencing (NGS) and fluorescence in situ hybridization (FISH).

In clinical trials, which monitored patients with NTRK gene fusion cancers, 75% of patients responded ‘positively’ to larotrectinib therapy. What is more, 73% of those who responded ‘positively’ were able to sustain the response for at least 6 months, while 22% evoked a ‘complete’ response, meaning that cancer advancement was stopped in its entirety.

The FDA advises patients eligible for larotrectinib therapy will:

  • Be adult or paediatric patients;
  • Have solid tumours which test positive for NTRK gene fusion;
  • Not have a known acquired resistance mutation;
  • Have metastatic tumours, or be at risk of severe morbidity if surgical resection is carried out; and
  • Have no satisfactory alternative treatments, or a lack of progression following prior treatment.

 

[1] FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion(1,2) (26 November 2018 LOXO ONCOLOGY) <https://ir.loxooncology.com/press-releases/2378241-Fda-approves-vitrakvi-larotrectinib-the-first-ever-trk-inhibitor-for-patients-with-advanced-solid-tumors-harboring-an-ntrk-gene-fusion12> accessed 31 January 2019.

[2] <https://www.hcp.vitrakvi-us.com/> accessed 31 January 2019.