Pharma Focus Asia

U.S. FDA approves Foundation Medicine’s FoundationOne®CDx as a companion diagnostic for Roche’s Rozlytrek® (entrectinib)

Friday, June 10, 2022

Roche today announced that the United States Food and Drug Administration (U.S. FDA) has approved Foundation Medicine’s FoundationOne®CDx as a companion diagnostic (CDx) for Roche’s Rozlytrek® (entrectinib). FoundationOne CDx is a comprehensive genomic profiling (CGP) pan-tumour tissue biopsy test that assesses an individual’s cancer to identify the unique molecular ‘fingerprint’ of the tumour. It is the first and only U.S. FDA-approved CDx to identify patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC), or patients with NTRK fusion-positive cancers, for whom treatment with Rozlytrek may be appropriate.

“The ability to tailor cancer therapies based on specific genomic alterations using validated comprehensive genomic profiling (CGP) has transformed the traditional ‘one-size fits-all’ approach to cancer,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “This approval marks a significant step forward in expanding treatment options and improving outcomes for patients, particularly those with rare tumours.”

Using CGP to identify the genomic alterations that are associated with driving an individual’s cancer can support physicians in making an informed treatment decision for the individual patient, potentially achieving better clinical outcomes.1

Rozlytrek is a targeted therapy approved to treat ROS1 fusion-positive metastatic NSCLC and a tumour-agnostic medicine for locally advanced or solid tumours that harbour NTRK fusions. ROS1 gene fusions account for 1-2% of NSCLC, the most common type of lung cancer that accounts for up to 85% of all diagnoses.2,3 NTRK gene fusions have been identified in a range of solid tumour types, and are present in up to 90% of some rare cancer types and less than 1% of other more common cancers, including lung and colorectal.4 

The approval is based on data from the phase I ALKA-372-001 (EudraCT 2012-000148-88), phase I STARTRK-1 (NCT02097810) and phase II STARKTRK-2 (NCT02568267) trials. As a condition of this approval, Foundation Medicine will conduct a post-approval study powered by the Flatiron Health-Foundation Medicine’s Clinico-Genomic Database (CGDB) to further demonstrate FoundationOne CDx’s ability to identify patients with ROS1 fusion-mutated NSCLC for whom treatment with Rozlytrek may be appropriate. The CGDB is a de-identified, HIPAA-compliant database that links outcomes data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s CGP assays. The database currently contains more than 100,000 linked genomic profiles , and is continually growing.

By combining tumour-agnostic drug development with data collection, high-quality diagnostics and the implementation of CGP, Roche is leading the realisation of personalised healthcare around the world, enabling physicians to develop tailored treatment strategies for each individual, and enable smarter, more efficient research and development to ensure no person is left behind.

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