The conditional approval of fanregratinib is supported by pivotal phase 2 data showing a 42.5% objective response rate in pretreated FGFR2-altered intrahepatic cholangiocarcinoma.
The sNDA is supported by VIKTORIA-1 Study 2 data showing that gedatolisib-based regimens approximately doubled median PFS vs alpelisib plus fulvestrant.
The European Commission approved sacituzumab govitecan plus pembrolizumab for treatment-naive, PD-L1-positive metastatic triple-negative breast cancer.
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