FDA clears FoundationOne® CDx for Vitrakvi

October 27, 20200

FoundationOne®CDx  by Foundation Medicine, a Roche subsidiary, received FDA clearance under accelerated review and is the first companion diagnostic capable of detecting patients with Neurotrophic Receptor Tyrosine Kinase (NTRK) gene fusionThe test will assist in the identification of cancer patients with neurotrophic receptor tyrosine kinase fusions for treatment with Bayer’s Vitrakvi (Larotrectinib). FoundationOne®CDx is a comprehensive companion diagnostic test for solid tumors and the approval adds on to the multiple companion diagnostic indications in solid tumors, including melanoma, breast cancer, non-small lung cancer etc. 

Bayer and Foundation Medicine forged a global collaboration earlier in May 2019 focused on synergising efforts to develop Next-Generation Sequencing (NGS) based companion diagnostics for Bayer’s oncology portfolio, including VitrakviTRK inhibitor used for the treatment of patients with TRK fusion cancer. Foundation’s comprehensive genomic profiling test analyses 324 genes for substitutions, deletion, insertion and alterations in solid tumor samples to identify the appropriate set of subjectwith NTRK 1/2/3 gene fusions. This will enable clinicians to make informed decisions regarding the treatment pathway and will expand access to drugs for better patient care.  

Chugai Pharmaceuticals, Japanese partner of Foundation Medicine filed an application at the Ministry of Health, Labour and Welfare (MHLW), Japan, to obtain an approval for expanded use for the same companion diagnostic for VitrakviThe deal indicates the big pharma’s focus on forging partnerships to continue the momentum of precision oncology by seeking novel mechanisms for identifying target patients. AstraZeneca’s Tagrisso (osimertinibalso received US FDA’s approval for a companion diagnostic through liquid biopsy for the confirmation of the presence of a T790M mutation in patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). NGS based companion diagnostics have been commercialised for multiple oncology indications in the past few years, making way for better patient care through precision medicine 

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