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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 diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.
Invitae will provide free genetic testing on a 53-gene panel and counseling to patients suspected of having an LSD to facilitate earlier diagnosis and appropriate treatment.
The agency compiled the evolving list by drawing on information from drug labeling and the published literature and is asking stakeholders to provide feedback.
Genentech will use Adaptive's ClonoSeq assay for MRD testing in a CLL study. Adaptive will receive upfront and sample testing payments of undisclosed amounts.
Cancer immunotherapy is an exciting new advance for the successful treatment of many forms of metastatic cancer.