GI CANCERS

New RASolute trials test daraxonrasib for metastatic and resected pancreatic cancer, comparing combos and follow-up use to improve outcomes.

The approval of lutetium Lu 177 dotatate injection for GEP-NETs is based on results from the ERASMUS study.

The FDA will use the extension to review additional data supporting the NDA for zanzalintinib plus atezolizumab for metastatic colorectal cancer.

The FDA has approved Omcazio, a capsule-based formulation of cabozantinib as a laurylsulfate salt, that demonstrated bioequivalence to the existing tablet.

Geoffrey Y. Ku, MD, highlights emerging therapies in the treatment paradigm for patients with gastric and gastroesophageal junction cancers.

The OS findings follow the recent FDA approval of zanidatamab with or without tislelizumab in HER2-positive gastroesophageal cancer.

Shubham Pant, MD, MBBS, explains the significance of the FDA approval of daraxonrasib for mPDAC.

Varsetatug masetecan is a first-in-class ADC that pairs a monoclonal antibody against EpCAM with a topoisomerase 1 inhibitor payload.

ERAS-0015 is being tested in AURORAS-1, an open-label study enrolling patients with RAS-mutant solid tumors.

The assays are now approved to assess HER2 status in gastric, gastroesophageal junction, and esophageal adenocarcinoma.

The approval of daraxonrasib in pancreatic cancer is supported by results from the phase 3 RASolute 302 trial.

The benefit of daraxonrasib in PDAC may be overstated in RASolute 302 due to informative censoring.

The FDA approved 2 zanidatamab-based regimens for first-line HER2-positive gastroesophageal adenocarcinoma, based on phase 3 HERIZON-GEA-01 data.

The sBLA for dostarlimab in dMMR/MSI-H rectal cancer is based on the AZUR-1 trial.

"New clinical evidence helps clarify which patients can benefit from radiation therapy,” said Daniel Chang, MD.

The complete response letter did not cite any clinical issues regarding the NDA for 177Lu-edotreotide for GEP-NETs.

A South Korean cohort shows that heavy drinking sharply raises liver cancer risk after age 60, guiding age-tailored screening and prevention.

FDA grants orphan status to DLL3-targeting ADC zocilurtatug pelitecan, boosting hopes for new options in hard-to-treat neuroendocrine cancers.

After encouraging early data were released, the FDA granted breakthrough therapy designation to olomorasib, an oral KRAS G12C inhibitor, for the treatment of previously treated advanced pancreatic cancer.

FDA tentatively OKs cabozantinib capsules for renal cell carcinoma, hepatocellular carcinoma, and epNETs, with dose-conversion guidance, error warning, and improved absorption.

SimpleScreen CRC has demonstrated a sensitivity of 81.1% for CRC detection.

Sonesitatug vedotin boosted overall survival vs chemotherapy in second-line and later CLDN18.2-positive gastric/GEJ cancers.

The NDA for daraxonrasib in PDAC is supported by results from the phase 3 RASolute 302 trial.

The designation for pelareorep was supported by results from the phase 1/2 GOBLET study.

National BRFSS study reveals SOGI adults lag in cervical and breast cancer screening; gaps are linked to insurance, access, and stigma.