2021-07-18| Trials & Approvals

FDA Approves Foundation Medicine’s Liquid Biopsy Test as Companion Diagnostic for Novartis’ Tabrecta

by Rajaneesh K. Gopinath
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Cambridge, MA-based Foundation Medicine (FMI) announced that the FDA greenlit its liquid biopsy assay as a companion diagnostic to Novartis’ kinase inhibitor, Tabrecta.

Lung cancer is the second most common cancer, which makes up for 13% of all new cases. NSCLC accounts for 85% of all lung cancer diagnoses, with the METex14 alteration associated with 3 to 4% of them.

On July 15th, the US drugmaker approved FoundationOne Liquid CDx to identify patients with NSCLC harboring the MET exon 14 (METex14) skipping alteration. This is now the assay’s ninth FDA approval as a companion diagnostic for targeted therapies across four cancer types.

“For lung cancer patients with METex14, having the option of a non-invasive liquid biopsy expands access to this first-of-its kind therapy and helps meet a critical patient need,” said Dr. Brian Alexander, CEO at Foundation Medicine.


Fourth Companion Diagnostic for Novartis’ Oncology Portfolio

FoundationOne Liquid CDx is a blood-based CGP tool that analyzes short variants in over 300 cancer-related genes for various genomic alterations. It includes mutations in homologous recombination repair (HRR) genes such as BRCA1 and BRCA2, in circulating cell-free DNA and subsequently helps match the mutations for specific FDA-approved therapies.

Earlier, in May 2020, FMI’s comprehensive genomic profiling test, FoundationOne CDx was also approved as a companion diagnostic for Tabrecta. The latest approval marks FMI’s fourth as companion diagnostic for the Novartis portfolio of targeted oncology therapeutics, the company said in a statement.

“This approval, coupled with last year’s simultaneous therapy and companion diagnostic approval for Tabrecta and our tissue test, FoundationOne CDx, is an important advancement and demonstrates the value of having multiple highly-validated comprehensive genomic testing options for physicians to consider for the individual needs of each patient.” Dr. Alexander added.

Related Article: The Maturation of Blood-Based Diagnostics to Nip Cancers in the Bud: An Interview with Dr. Jimmy Lin

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