Reassessing Trial Endpoints for CRPC

The FDA approved lirafugratinib in FGFR2+ cholangiocarcinoma and belzutifan plus lenvatinib in advanced ccRCC, and more.

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FDA grants priority review to durvalumab plus enfortumab vedotin for cisplatin-ineligible MIBC based on positive phase 3 VOLGA data.

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.

The CHMP recommended perioperative pembrolizumab plus enfortumab vedotin for resectable muscle-invasive bladder cancer.

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.

KST-6051 received FDA fast track designation for KRAS-mutant solid tumors.