Daiichi Sankyo and Merck withdrew the I-DXd BLA in ES-SCLC after FDA discussions found phase 2 IDeate-Lung01 data insufficient for accelerated approval.
The FDA has approved belzutifan (Welireg) plus lenvatinib (Lenvima) for use in patients with advanced renal cell carcinoma with a clear cell component after PD-1 or PD-L1 inhibition.
The addition of the β-catenin pathway inhibitor tegavivint to osimertinib produced deep responses in a phase 1b study in first-line EGFR-mutated NSCLC.