FDA Approves Oncomine DX Target Test as Companion Diagnostic for RET+ Thyroid Cancer and NSCLC

The Oncomine Dx Target Test was granted approval by the FDA as a companion diagnostic for RET fusion–positive thyroid cancer and RET fusion–positive non–small cell lung cancer.

The FDA has granted approval to the Oncomine Dx Target Test as a companion diagnostic to help in identifying RET fusions in locally advanced or metastatic non-small cell lung cancer (NSCLC), advanced/metastatic thyroid cancer, or advanced/metastatic medullary thyroid cancer (MTC) in patients who may be eligible for selpercatinib (Retevmo), according to press release from Thermo Fisher Scientific.1

The next-generation sequencing (NGS)–based Oncomine Dx Target Test can use small samples to detect multiple mutations simultaneously. The test could help in selecting a targeted therapeutic strategy based on the detected alterations. Seventeen countries have granted the test regulatory approval for 15 targeted therapies.

“Following the Oncomine Dx Target Test’s first approval in 2017, we have worked to advance access to companion diagnostics for targeted therapies on a global scale,” said Garret Hampton, President and Clinical Next generation Sequencing and Oncology of Thermo Fisher Scientific, during the press release. “As we continue to pursue additional approvals alongside our biopharma partners, we remain committed to broadening access to NGS-based testing to ensure patients and clinicians everywhere can benefit from it.”

Selpercatinib was granted full approval by the FDA in September 2022 as a treatment for RET fusion–positive NSCLC.2 The FDA granted the agent an accelerated approval in May 2020 that was supported by findings from the phase 1/2 LIBRETTO-001 trial (NCT03157128), which was designed to assess the safety and efficacy of selpercatinib in advanced RET fusion–positive solid tumors and MTC.

The ORR was 84% (95% Confidence Interval [CI], 73%-92%) among treatment-naïve patients treated with the agent with a median duration of response (DOR) of 20.2 months. In the population previously treated with platinum-based chemotherapy, the ORR was 61% (95% CI, 55%-67%) with a median DOR of 28.6 months.

Frequent adverse effects included edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.

References

  1. Thermo Fisher Scientific announces FDA approval of Oncomine Dx Target Test as the first NGS-based companion diagnostic to aid in therapy selection for patients with RET mutations/fusions in thyroid cancers. News release. Thermo Fisher Scientific. September 27, 2022. Accessed September 28, 2022. https://bwnews.pr/3RfgH8p
  2. FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer. News release. FDA. September 28, 2022. Accessed September 22, 2022. https://bit.ly/3f6PjMm