FDA Approves True Sight Oncology Comprehensive Test to Identify NTRK Solid Tumors

The FDA approved an in vitro diagnostic (IVD) TruSight Oncology Comprehensive test (Illumina Inc) and the 2 companion diagnostic (CDx) indicators to identify pediatric and adult individuals with solid tumors that are positive for neurotrophic tyrosine receptor kinase (NTRK). By using the diagnostic test, patients who would benefit from larotrectinib (Vitrakvi; Bayer) can be identified efficiently.¹

Furthermore, the test can help identify adult patients with locally advanced or metastatic rearrangement during transfection fusion (RET)-positive non–small cell lung cancer (NSCLC) who could benefit from treatment with selpercatinib (Retevmo; Eli Lilly).¹

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"Through research conducted globally, there is a significant body of evidence demonstrating the clinical utility of comprehensive genomic profiling for patients with advanced cancer," Vivek Subbiah, MD, chief of early-phase drug development at Sarah Cannon Research Institute, said in a news release. "Illumina's newest distributable IVD kit for comprehensive genomic profiling and accompanying CDx enable another valuable clinical tool for the oncology community to match patients with targeted therapies that can vastly improve their journey and outcomes."¹

According the the news release, CDx tests identify a specific gene or biomarker that can be targeted by a specific therapy, helping physicians prescribe appropriate medications and informing the pharmacist on the patient’s condition. Oncology pharmacists are often involved in all phases of a patient’s treatment, from assessment and diagnosis to treatment decisions and medication management. Pharmacists and other health care providers help to ensure that the most appropriate therapy for the patient is selected, and with diagnostic tools, health care providers can help to identify treatments that have the best probability of working for a specific patient. Care for cancer patients can be lengthy and therapy is typically high cost, so choosing the best therapy for a patient is essential.^1,2

Most CDx tests are specific to 1 type of cancer, but the newly approved test can be used across solid tumor indications (NTRK diagnostic). NTRK has a prevalence of 1% in solid tumors, but is highly seen in rare tumors, which include mammary secretory carcinoma, mammary analogue secretory carcinoma of the salivary gland, and congenital infantile fibrosarcoma. In rare cancers, the frequency of NTRK gene fusion is approximately 80% compared with common cancer being 5% to 25%. For gene fusion, it's present in 90% to 100% of mammary analogue secretory carcinoma of the breast, more than 90% of mammotomy secretory, 91% to 100% of fibrosarcoma and 83% of congenital mesoblastic.^1,3

RET rearrangements in NSCLC is prevalent in approximately 1% to 2%. However, according to a study published in The Oncologist, patients are not always tested for RET, so patients who are eligible for targeted therapy of RET is below 1% to 2%. With the new approval, the diagnostic and use of targeted therapies for this type of cancer could improve.⁴

The new diagnostic test will begin shipping in the US this year and is already available in Europe.¹

REFERENCES

1. FDA approves Illumina cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies. News release. Illumina. August 27, 2024. Accessed August 27, 2024. https://prnmedia.prnewswire.com/news-releases/fda-approves-illumina-cancer-biomarker-test-with-two-companion-diagnostics-to-rapidly-match-patients-to-targeted-therapies-302230979.html

2. Hematology/Oncology Pharmacy Association. The Role of Hematology/Oncology Pharmacists.August 22, 2014. Accessed August 27, 2024. https://www.hoparx.org/documents/78/HOPA_About_Hem_Onc_Pharmacist_Issue_Brief_FINAL1.pdf

3. Manea CA, Badiu DC, Ploscaru IC, et al. A review of NTRK fusions in cancer. Ann Med Surg (Lond). 2022;79:103893. Published 2022 Jun 13. doi:10.1016/j.amsu.2022.103893

4. Novello S, Califano R, Reinmuth N, Tamma A, Puri T. RET Fusion-Positive Non-small Cell Lung Cancer: The Evolving Treatment Landscape. Oncologist. 2023;28(5):402-413. doi:10.1093/oncolo/oyac264