The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
The company is also looking to expand the use of its FDA-approved ClonoSeq assay, which has US FDA approval for MRD detection in acute lymphocytic leukemia and multiple myeloma.
Researchers showed, retrospectively, that using a cutoff of 16 circulating DNA mutations they could identify patients who were more likely to respond to immunotherapy.
Both recent FDA draft guidance and a new research framework encourage the use of biomarker diagnostics to assess Alzheimer's before symptoms emerge.
Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.
At the Personalized Medicine World Conference, stakeholders and the former FDA commissioner discussed how regulation can advance personalized medicine amid political uncertainty.
The FDA-approved complementary assay "can provide insight into the survival benefit that may be achieved" with the treatment, Roche said.
The recent failure of Bristol-Myers Squibb's lung cancer immunotherapy to meet its primary endpoint demonstrates the challenge of working with imperfect biomarkers.