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News and reporting on ROS1 biomarkers.
The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.
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.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
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.
In the JAMA study, researchers confirmed the previously known clinical and genomic features of NSCLC patients in their large clinico-genomics database.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
Almac is developing the assay to enroll patients for clinical trials used to develop repotrectinib, an investigational tyrosine kinase inhibitor.
Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.
Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.
The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.
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