NEW YORK – Thermo Fisher Scientific said on Tuesday that the US Food and Drug Administration has granted premarket approval for its Oncomine Dx Target Test as a companion diagnostic for pralsetinib (Gavreto), a targeted drug developed by Blueprint Medicines, to identify RET fusions in metastatic non-small cell lung cancer patients.
Thermo Fisher said the assay is the first and, so far, only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC, adding that it plans to update the test to enable it to report RET fusions in the US before the end of the year.
Blueprint Medicines signed a deal with Thermo Fisher in 2017 to develop and commercialize the Oncomine test as a CDx for pralsetinib.
"It is our goal to provide cancer patients globally greater access to highly actionable, [next-generation sequencing]-based multi-biomarker testing in important indications like NSCLC as recommended by multiple guidelines," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, in a statement. "Today's approval underscores this endeavor."
The Oncomine Dx Target Test, which evaluates 23 genes associated with NSCLC, was first approved by the FDA as a CDx in 2017 for biomarkers associated with three FDA-approved NSCLC therapies. In addition, the test has been approved by Japan's Ministry of Health, Labor, and Welfare as a CDx for four biomarkers associated with 12 targeted therapies for NSCLC.
In addition, Japan recently approved the test to assess patients for treatment with entrectinib (Genentech's Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical), following a CDx agreement between Thermo Fisher and Chugai this summer.
Pralsetinib, which targets RET fusions and mutations, was granted accelerated approval by the FDA last week for the treatment of adult patients with metastatic RET fusion-positive NSCLC, based on data from the ongoing Phase I/II ARROW clinical trial.
Roche signed a deal with Blueprint Medicines in July under which Blueprint and Roche subsidiary Genentech will co-commercialize pralsetinib in the US, and under which Roche will have exclusive commercialization rights for the drug outside the US except in certain countries in Asia.