The U.S. Food and Drug Administration (FDA) has granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received EGFR-directed therapy and platinum-based chemotherapy. This approval is based on clinical trial data demonstrating improved progression-free survival (PFS) of 8.2 months versus 4.5 months with chemotherapy in the ITT population, although overall survival (OS) was similar between the datopotamab deruxtecan arm (16.0 months) and chemotherapy arm (15.9 months). Additionally, the phase 2 OptiTROP-Lung03 trial showed sacituzumab tirumotecan improved PFS and OS compared to docetaxel in previously treated patients with locally advanced or metastatic EGFR-mutant nonsquamous NSCLC. Perioperative therapy with nivolumab improved event-free survival (EFS) versus placebo in patients with resectable NSCLC regardless of KRAS, KEAP1, or STK11 mutation status, with median EFS reaching 46.6 months versus 16.9 months. Neoadjuvant osimertinib alone or combined with chemotherapy showed improved major pathological response rates compared to chemotherapy alone in resectable EGFR-mutated NSCLC. Neoadjuvant nivolumab plus chemotherapy also demonstrated significant overall survival benefits over chemotherapy alone in resectable NSCLC patients. In small cell lung cancer (SCLC), tarlatamab treatment resulted in a median OS of 13.6 months compared to 8.3 months with chemotherapy. Separately, the FDA granted accelerated approval to Lynozyfic (linvoseltamab-gcpt), a BCMAxCD3 bispecific antibody by Regeneron Pharmaceuticals, for relapsed or refractory multiple myeloma after four or more prior therapies, based on response data from the LINKER-MM1 trial. Other notable regulatory updates include FDA priority review for the combination of lurbinectedin and atezolizumab for first-line maintenance treatment of extensive-stage SCLC and China's NMPA breakthrough therapy designation for sacituzumab tirumotecan plus tagitanlimab in locally advanced or metastatic nonsquamous NSCLC without actionable genomic alterations.