AMERICAN SOCIETY OF CLINICAL ONCOLOGY

The FDA granted accelerated approval to zenocutuzumab-zbco as the first systemic therapy for patients with NSCLC or PDAC harboring an NRG1 gene fusion. The approval is supported by the phase 1/2 eNRGy trial, which showed ORRs of 33% in NSCLC and 40% in PDAC, with median DORs of 7.4 months and 3.7 to 16.6 months, respectively. Zenocutuzumab also demonstrated a well-tolerated safety profile.

FDA approves zenocutuzumab for NRG1+ NSCLC and PDAC, supported by phase 1/2 eNRGy trial. It's the first targeted therapy for these cancers, with ORR of 33% in NSCLC and 40% in PDAC.

The FDA granted sacituzumab tirumotecan (SKB264/MK-2870) breakthrough therapy designation for advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) with EGFR mutations, post-TKI and platinum-based chemotherapy progression. This decision is supported by phase 2 study data, marking the first BTD for the agent in the US.

Ralph R. Weichselbaum, MD, appointed University of Chicago Health System leader for Radiation and Cellular Oncology, expanding radiation therapy to patients in Chicago’s suburbs and Northwest Indiana. UChicago Medicine’s cancer program ranked No. 1 in Illinois, constructing the state’s first freestanding cancer care facility, the AbbVie Foundation Cancer Pavilion, set to open in 2027. Weichselbaum continues as Chair of the Department of Radiation and Cellular Oncology, overseeing Illinois’ largest integrated academic program and research collaborations, recognized for contributions to radiation oncology and cancer research.

FDA grants Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for treating advanced EGFR-mutated NSCLC after TKI and platinum-based chemotherapy failure, based on Phase 2 study data.

The FDA granted Breakthrough Therapy Designation to Merck’s sacituzumab tirumotecan (sac-TMT) for advanced or metastatic nonsquamous non-small cell lung cancer with EGFR mutations, supported by Phase II study data. Merck aims to improve current standards of care with ADCs, advancing sac-TMT in monotherapy and combination with Keytruda in various solid tumors. Lung cancer is the leading cause of cancer mortality in the U.S., with NSCLC being the most common form. Sac-TMT also received its first marketing authorization in China for triple-negative breast cancer treatment.

FDA grants breakthrough therapy designation to sacituzumab tirumotecan for advanced EGFR-mutated NSCLC patients who progressed on TKI and platinum-based chemotherapy. Merck emphasizes the importance of ADCs in cancer treatment and is advancing sac-TMT's clinical development.

FDA grants Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for treating advanced or metastatic nonsquamous non-small cell lung cancer with EGFR mutations after progression on TKI and platinum-based chemotherapy. Sac-TMT is an investigational TROP2-directed ADC developed with Kelun-Biotech, based on Phase 2 data from a Phase 1/2 study and a Phase 2 study.

FDA grants Breakthrough Therapy designation to Merck's sacituzumab tirumotecan (sac-TMT) for advanced EGFR-mutated NSCLC, based on Phase 2 data. Sac-TMT, a TROP2 ADC, is also being evaluated in 10 Phase 3 studies, including TroFuse-004 and TroFuse-009. Additionally, sac-TMT received its first marketing authorization in China for treating TNBC.

Merck announced FDA Breakthrough Therapy designation for sacituzumab tirumotecan (sac-TMT) for EGFR-mutated NSCLC, based on Phase 2 study results. Merck is advancing sac-TMT's clinical development to improve cancer care, with ongoing Phase 3 studies and a first marketing authorization in China for TNBC.