FDA Accepts BMS's NDA for Repotrectinib in ROS1-Positive NSCLC
The agency is reviewing data from the Phase II TRIDENT trial and expects to decide whether to approve the drug by November 27.
Foundation Medicine, Bristol Myers Squibb Expand CDx Partnership to Investigational Cancer Drug
The companies are working to establish FoundationOne CDx as a companion diagnostic for BMS's investigational tyrosine kinase inhibitor repotrectinib.
Guardant Health, AnHeart Tx to Develop Blood- and Tissue-Based CDx for NSCLC Drug
The companies will jointly develop and commercialize Guardant360 CDx and Guardant360 TissueNext for taletrectinib treatment in advanced and metastatic NSCLC.
Alercell to Distribute Amoy Diagnostic Ros1 Gene Fusion Detection Kit in US
The 14-fusion PCR assay for lung cancer subtyping is available for research-use only but will be more broadly distributed when the kits gain FDA clearance.
Turning Point Therapeutics Receives Positive FDA Feedback on Repotrectinib NSCLC Application
Regulators agreed with the firm's plan to file data from both previously treated and treatment-naïve advanced ROS1-positive non-small cell lung cancer patients.