Lung Cancer
Personalis, Tempus Partner to Commercialize Blood-Based Minimal Residual Disease Test
Tempus will market Personalis' NeXT Personal Dx liquid biopsy while Personalis completes its clinical validation in more indications.
AnHeart Therapeutics, Innovent Biologics File for Taletrectinib NSCLC Approval in China
Chinese regulators accepted a new drug application for taletrectinib in pretreated non-small cell lung cancer patients whose tumors harbor ROS1 gene fusions.
Janssen Seeking FDA Approval for Rybrevant-Chemo in EGFR-Mutated NSCLC After Prior Tagrisso Therapy
The firm filed a supplemental biologics licensing application seeking approval for the combination based on data from the Phase III MARIPOSA-2 clinical trial.
FDA Approves BMS's Augtyro for Advanced ROS1-Positive NSCLC
The approval is based on results from the Phase I/II TRIDENT-1 clinical trial of Augtyro in both TKI-pretreated and TKI-naïve ROS1-positive NSCLC.
Foundation Medicine, Pierre Fabre Laboratories to Collaborate on CDx for Lung Cancer
The companies will seek approval for Foundation Medicine's assays identifying patients for treatment with Pierre Fabre's BRAF/MEK inhibitor combination regimen.