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Foundation Medicine to Seek FDA Approval for FoundationOne as CDx to Genentech's Rozlytrek

NEW YORK – Roche said today that its Foundation Medicine subsidiary intends to submit an application to the US Food and Drug Administration to get its FoundationOne CDx assay approved as a companion diagnostic for entrectinib (Genentech's Rozlytrek).

The FDA announced yesterday that it had granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients whose cancers have NTRK gene fusions and who are out of treatment options. The agency simultaneously approved Rozlytrek for adults with metastatic non-small cell lung cancer whose tumors are ROS1-positive. 

Biomarker testing for ROS1 in NSCLC and NTRK gene fusions across all solid tumours is the only way to identify people who are eligible for treatment with Rozlytrek, Roche said. There is currently no FDA-approved CDx for Rozlytrek at this time, though the company believes FoundationOne CDx can fill that niche.

FoundationOne CDx — which detects mutations in 324 genes, select gene rearrangements, and genomic signatures including microsatellite instability and tumor mutational burden — already has FDA approval for use in all solid tumors and incorporates multiple companion diagnostics for a total of 18 FDA-approved targeted therapies.

Rozlytrek is the third drug the FDA has approved with a pan-cancer indication. It has also approved pembrolizumab (Merck's Keytruda) for solid tumors with high microsatellite instability and mismatch repair deficiency, and larotrectinib (Bayer and Loxo Oncology's Vitrakvi) in solid tumors with NTRK fusions.

The agency approved the drug based on data from four trials involving 54 adults with NTRK-positive tumors, with lung, salivary gland, breast, thyroid, and colon/rectum cancers being most common. In these studies, 57 percent saw their tumors shrink, and 7.4 percent saw their tumors completely disappear. Of the 31 patients who responded, 61 percent experienced tumor shrinkage for nine months or longer.

The approval for the NSCLC indication was based on a study involving 51 adults with ROS1-positive lung cancer, in which 78 responded and nearly 6 percent had a complete response. Out of 40 responders, 55 percent experienced tumor shrinkage for 12 months or longer.

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