FDA Approves ctDx FIRST Companion Diagnostic for KRAS G12C-Mutated NSCLC

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The FDA has approved the Agilent Resolution ctDx FIRST assay for identifying patients with KRAS G12C–mutated non–small cell lung cancer who may benefit from adagrasib.

Agilent Resolution ctDx FIRST has been granted approval by the FDA as a companion diagnostic for patients with non–small cell lung cancer (NSCLC) harboring KRAS G12C mutations who may be eligible to receive adagrasib (Krazati), according to a press release from Agilent Technologies.

The ctDX FIRST assay is also able to be used for tumor profiling of EGFR genes by qualified health care professionals for patients with NSCLC based on guidelines.

The Agilent Resolution ctDx FIRST is the first liquid biopsy assay to receive approval for identifying patients with advanced NSCLC who are good candidates for treatment with adagrasib. The FDA also approved the QIAGEN therascreen KRAS RGQ PCR kit for testing tumor tissues if the ctDx FIRST assay does not detect mutations in a plasma specimen.

“Commercializing the ctDx FIRST test enables us to support clinicians to positively impact the lives of patients with advanced NSCLC,” Sam Raha, president of the Diagnostics and Genomics Group at Agilent, said in the press release.

The ctDx FIRST assay uses plasma samples to detect genomic alterations in circulating tumor DNA. The test was designed to offer oncologists and patients with advanced NSCLC a minimally invasive blood test with a faster turn-around time for clarifying precision treatment options compared with tissue-based methods.

The ctDx FIRST test report includes profiling on 109 genes in 4 types of alterations, which include single nucleotide variants, insertions and deletions, copy number amplifications, and gene fusions.

“Expanding access to accurate and fast genomic profiling is an essential step to unlocking important medicines for patients in desperate need,” Kenna Anderes, vice president of Translational Medicine and Companion Diagnostics at Mirati, said in the press release.

Adagrasib received accelerated approval from the FDA for the treatment of patients with KRAS G12C-mutated NSCLC in December 2022.2 The regulatory designation was based on findings from the phase 2 KRYSTAL-1 trial (NCT03785249), which highlighted an objective response rate of 43% (95% CI, 34%-53%). The median duration of response was 8.5 months (95% CI, 6.2-13.8). The study included a total of 112 patients, of whom 42% experienced a partial response and 37% had stable disease.

Common adverse effects included diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, and edema.

References

  1. Agilent Resolution ctDx FIRST receives FDA approval as a liquid biopsy companion diagnostic test for advanced non-small cell lung cancer. News release. Agilent Technologies. December 12, 2022. Accessed December 19, 2022. bit.ly/3Ws2YOj
  2. FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC. News release. FDA. December 12, 2022. Accessed December 19, 2022. https://bit.ly/3UUVphS
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