Artificial Intelligence Drives Industry Response to Project Optimus
February 27th 2024The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.
FDA Approves New Biweekly Reduced Dosing of Tecvayli Based on Phase I/II MajesTEC-1 Trial Data
February 21st 2024The Phase I/II MajesTEC-1 trial (NCT03145181; NCT04557098) evaluated Tecvayli (teclistamab-cqyv) at a reduced dose of 1.5 mg/kg administered every two weeks in patients with relapsed/refractory multiple myeloma.
Phase III INDIGO Trial Data Lead to FDA Priority Review for Vorasidenib in IDH-Mutant Gliomas
February 20th 2024Data from the pivotal, global, randomized, double-blind, placebo-controlled, Phase III INDIGO trial show statistically significant and clinically meaningful progression-free survival for vorasidenib treating IDH-mutant gliomas.
Phase III OUtMATCH Trial Findings Lead to FDA Approval of Xolair to Treat Multiple Food Allergies
February 16th 2024In clinical trials, Xolair was found to significantly increase the amount of peanuts, milk, egg, and cashew that it takes to trigger an allergic reaction in participants with food allergies.
FDA Upgrades Tepmetko to Full Approval for Metastatic NSCLC Based on VISION Trial Data
February 16th 2024Single-arm, open-label, multicenter, non-randomized, multicohort Phase II VISION trial (NCT02864992) of Tepmetko (tepotinib) for metastatic non–small cell lung cancer shows favorable objective response rate.