Treatment identifies patients with ROS1 fusion-positive non-small cell lung cancer or patients with NTRK fusion-positive solid tumors for whom Rozlytrek treatment may be appropriate.
The FDA has approved FoundationOne CDx (Foundation Medicine) as a companion diagnostic (CDx) forentrectinib (Rozlytrek; Roche), according to a statement from Roche.
FoundationOne CDx is a comprehensive genomic profiling (CGP) pan tumor tissue biopsy test that assesses a person’s cancer to identify the tumor’s unique molecular fingerprint. It is the first and only FDA-approved CDx to identify individuals with ROS1-fusion-positive non-small cell lung cancer (NSCLC) or individuals with NTRK fusion-positive cancers, for whom treatment with entrectinib may be appropriate.
“The ability to tailor cancer therapies based on specific genome changes using validated CGP has transformed the traditional ‘one-size-fits-all’ approach to cancer,” said Levi Garraway, MD, PhD, CEO and head of Global Product Development at Roche, in the statement. “This approval marks an important step forward in expanding treatment options and improving outcomes for patients, especially those with rare tumors.”
Using CGP to identify the genomic changes associated with directing cancer in a person could support physicians in making informed treatment decisions, potentially leading to better clinical outcomes.
Entrectinib is a targeted therapy approved for the treatment of ROS1-fusion-positive metastatic NSCLC and a tumor-independent drug for locally advanced or solid tumors harboring NTRK fusions.
ROS1 gene fusions account for 1% to 2% of NSCLC, the most common type of lung cancer accounting for up to 85% of all diagnoses, according to the statement.
NTRK gene fusions have been identified in a range of solid tumor types and are present in up to 90% of some rare cancers and less than 1% of other more common cancers, including colorectal and lung cancers, according to the statement.
FoundationOne’s approval is based on data from the Phase 1 ALKA-372-001, Phase 1 STARTRK-1 and Phase 2 STARTRK-2 studies.
As a condition of approval, Foundation Medicine will conduct a post-approval study, powered by Flatiron Health-Foundation Medicine’s Clinico-Genomic Database (CGDB), to assess the ability of FoundationOne CDx to identify individuals with ROS1-fusion-mutated NSCLC for whom the treatment with entrectinib may be appropriate.
The CGDB is an unidentified, Health Insurance Portability and Accountability Act of 1996 compliant database that links outcome data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s CGP assays. The database contains over 100,000 linked genomic profiles and is constantly growing.
FoundationOne CDx is a next-generation sequencing-based in vitro diagnostic test for the detection of substitution, insertion, deletion and copy number alteration in 324 genes and selected gene rearrangements, as well as genomic signatures, including microsatellite instability and tumor mutation burden, using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens.
Entrectinib is a tumor-independent oral medication for the treatment of locally advanced or metastatic solid tumors harboring NTRK 1/2/3 or ROS1 gene fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins, the activating fusions of which stimulate the proliferation of certain cancers.
The US FDA approves Foundation Medicine’s FoundationOne CDx as a companion diagnosis to Roche’s Rozlytrek (entrectinib). Roche. news item. June 9, 2022. Accessed June 10, 2022. https://www.roche.com/media/releases/med-cor-2022-06-09b