September 20th 2024
Final guidance suggests sponsors select two doses for Phase II trials with additional data requirements.
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.
Eohilia Approved by FDA to Treat Eosinophilic Esophagitis in Patients 11 Years of Age and Older
February 12th 2024Two multicenter, randomized, double-blind, placebo-controlled clinical trials showed that 53.1% of patients administered Eohilia achieved histologic remission compared with 1% of patients administered placebo.
FDA Places Hold on Clinical Trials of Magrolimab for Blood Cancers
February 8th 2024Gilead announced it will discontinue the clinical development of magrolimab for hematologic cancers after the drug in combination with azacitidine plus Venclexta showed an increased risk of death related to infections and respiratory failure in patients with acute myeloid leukemia.
FDA Grants Fast Track Designation to Next-Generation ADC Based on Phase I/II Trial Data
February 6th 2024The ongoing Phase I/II NCT05438329 trial is evaluating BNT325/DB-1305 in patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.
Phase III Trial Data Leads to FDA Priority Review of sBLA for Expanded Indication of Arexvy for RSV
February 6th 2024The supplemental Biologics License Application for Arexvy was based on positive data from the Phase III NCT05590403 trial, which analyzed the immune response and safety of Arexvy in individuals 50-59 years of age with an elevated risk of respiratory syncytial virus-related lower respiratory tract disease.