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ROS1 Biomarkers

News and reporting on ROS1 biomarkers.

The Chinese drug evaluation agency has granted the investigational new drug clinical trial authorization to taletrectinib in NRTK- and ROS1-mutated cancer patients.

National Institute for Health and Care Excellence draft guidance suggests more data is needed before using larotrectinib to treat UK cancer cases in histology-independent setting.

The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.

The ROS1ders advocacy group is 500 patients strong and they are helping researchers establish cell lines to improve understanding of rare ROS1-positve cancers. 

An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.

This is the third drug the agency has approved with a pan-cancer indication.

The study plans to recruit close to 300 patients with advanced non-small cell lung cancer, with half being treated based on liquid biopsy results.

Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.

Researchers are collecting genomic and clinical data on cancer patients outside of clinical trials to understand tumor biology, treatment efficacy, and care gaps.

In the Phase I/IB study, only patients with NTRK or ROS1 fusions, or an ALK fusion or mutation responded to entrectinib, while patients without these tumor markers didn’t respond.

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