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The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The goal of the LLS PedAI study is to investigate the efficacy and safety of multiple precision oncology drugs at once for children with relapsed acute leukemia.
The genetic classifications determined by the LymphGen tool could help shed light on the heterogenous responses of DLBCL to chemotherapy and molecularly targeted therapies.
The European Commission will now consider whether to grant marketing authorization to the drug regimen.
Following the accelerated approval for tazemetostat last month, the new supplement application could poise it as the first EZH2 inhibitor for follicular lymphoma.
The trial will enroll patients with CXCR4-mutated Waldenström’s macroglobulinemia and study the safety and tolerability of mavorixafor and ibrutinib.
Researchers at BostonGene and Weill Cornell Medicine hope their approach may provide a more complete and precise characterization of diffuse large B-cell lymphomas.
Kura Oncology said that it intends to enroll more patients for a registration-directed Phase II trial in 2020 following positive FDA feedback.
The companies will use Freenome's platform to identify cancer patients who are most likely to respond to treatment with ADC's loncastuximab tesirine.
In a Phase II trial, Sophia will look for genomic markers of clinical response to ADC's treatment for relapsed or refractory diffuse large B-cell lymphoma.