The FDA has cleared an sNDA updating the taletrectinib (Ibtrozi) label with new DOR data in TKI-naive patients with locally advanced or metastatic ROS1-positive NSCLC.
A marketing authorization application for lirafugratinib in previously treated FGFR2-altered metastatic cholangiocarcinoma has been submitted to the EMA.
Daraxonrasib plus gemcitabine and nab-paclitaxel received FDA breakthrough therapy designation for treatment-naive metastatic pancreatic adenocarcinoma.