Although the agency said the benefits of these treatments still outweigh their risks, it is investigating the potential for serious adverse outcomes and assessing the need for regulatory action.
In the LUMINOSITY trial, patients with EGFR wild-type advanced NSCLC had overall response rates of 23 percent to 35 percent based on their level of c-Met overexpression.
The firm will evaluate its autologous tumor-infiltrating lymphocyte therapy candidate in melanoma, head and neck cancer, and non-small cell lung cancer.
Following clearance of the investigational new drug application, the company is planning a first-in-human dose escalation trial in the US.
Investigators are using the firm's liquid biopsy system to collect blood samples and identify proteins and biomolecules relevant to pathobiology.
Tempus will market Personalis' NeXT Personal Dx liquid biopsy assay while Personalis completes its clinical validation in more indications.
The recipients of both grants will study the effects of bringing next-generation sequencing-based testing into a community cancer center.
The FDA cleared the firm's investigational new drug application to study its autologous cell therapy CT-0525 in patients with solid tumors overexpressing HER2.
By reducing staff and lowering its operating costs, Candel expects to fund operations into the fourth quarter of 2024.
Quest will provide RNA extraction and sequencing services for Scipher's PrismRA test, a blood-based molecular test for predicting patient response to TNF inhibitors.