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FDA Approves Thermo Fisher Scientific Oncomine Dx Assay as CDx for Janssen Lung Cancer Drug

NEW YORK – Thermo Fisher Scientific said on Thursday that the US Food and Drug Administration has granted premarket approval to the company's Oncomine Dx Target Test as a companion diagnostic for Janssen Biotech's targeted lung cancer treatment amivantamab-vmjw (Rybrevant).

The approval allows the use of Oncomine Dx to help identify non-small cell lung cancer patients whose tumors carry epidermal growth factor receptor Exon 20 insertion mutations for potential treatment with amivantamab-vmjw, the company said.

According to Janssen, amivantamab-vmjw is the first fully human, bispecific antibody approved for treatment of lung cancer. The drug is targeted against EGFR and MET receptors and binds extracellularly to inhibit tumor growth and lead to tumor cell death. It was granted accelerated approval by the FDA in May for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR Exon 20 insertion mutations — as detected by an FDA-approved test — whose disease has progressed on or after platinum-based chemotherapy.

The Oncomine Dx Target Test is a next-generation sequencing assay that was first approved by the FDA as a CDx in 2017, and it is now approved for six targeted therapies for NSCLC and one targeted therapy for cholangiocarcinoma in the US. The assay simultaneously evaluates 23 genes associated with NSCLC.

This is the second approval for Oncomine Dx as a CDx for EGFR Exon 20 insertion mutant patients, Thermo Fisher added. In September, the FDA granted accelerated approval to Takeda Pharmaceutical's mobocertinib (Exkivity) for previously treated, metastatic NSCLC cancers harboring EGFR Exon 20 insertion mutations, and simultaneously approved the Oncomine Dx Target Test as a CDx for the drug.

"The FDA's approval of Oncomine Dx Target Test enables clinicians to use FFPE tissue samples to identify patients in the US who may benefit from this important new therapy," Garret Hampton, president of Thermo Fisher's clinical next-generation sequencing and oncology business, said in a statement. "In situations where conventional testing may miss key mutations that could match patients with targeted therapies, NGS technology is vital to make these connections and advance precision medicine."

The test has also been approved by Japan's Ministry of Health, Labor, and Welfare as a CDx for five biomarkers — EGFR, ALK, ROS1, BRAF, and RET — associated with 10 targeted therapies for NSCLC. In September, Japan's MHLW granted approval for Oncomine Dx to be used as a companion diagnostic to identify patients with RET-fusion positive NSCLC who may be candidates for treatment with Eli Lilly's selpercatinib (formerly known as LOXO-292).

The test's approval for cholangiocarcinoma came in August when it was granted premarket approval as a CDx to identify patients with isocitrate dehydrogenase-1-mutated CCA who may be candidates for treatment with ivosidenib (Servier Pharmaceuticals' Tibsovo).

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