Quizartinib Plus Chemo Gains FDA Approval for Newly Diagnosed, FLT3-ITD+ AML
July 21st 2023Quizartinib has been approved by the FDA for use with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy after consolidation chemotherapy, to treat adults with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive, as detected by an FDA-approved test.
Trastuzumab Deruxtecan Elicits Durable Response in HER2+ Gastric/GEJ Cancer
July 19th 2023Trastuzumab deruxtecan elicited a confirmed objective response rate of 42% in patients with HER2-positive gastric or gastroesophageal junction cancer, according to findings from the phase 2 DESTINY-Gastric02 trial.
Delayed HRQOL Outcomes Are Observed With Lutetium Lu 177 Vipivotide Tetraxetan in mCRPC
July 18th 2023The onset of skeletal events and events that affect health-related quality of life were delayed with the addition of lutetium Lu 177 vipivotide tetraxetan to standard of care for patients with metastatic castration-resistant prostate cancer.
Adagrasib Elicits Intracranial Response in NSCLC With KRAS G12C Mutations, Untreated CNS Metastases
July 17th 2023Findings from the phase 1b cohort of the KRYSTAL-1 trial underscore the intracranial permeation of the KRAS G12C inhibitor adagrasib for patients with non–small cell lung cancer with untreated central nervous system metastases.
Zolbetuximab BLA Undergoes Priority Review for CLDN18.2+ Advanced Gastric/Gastroesophageal Cancer
July 11th 2023The FDA has granted priority review to the biologics license application for zolbetuximab as a treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.