EP. 3: FDA Fast Tracks UV1, Ipilimumab, and Nivolumab in Malignant Mesothelioma
February 5th 2024A fast track designation to UV1 combination therapy for malignant mesothelioma from the FDA signifies expedited review and development for a promising treatment option, offering hope for patients with malignant pleural mesothelioma.
EP. 12: BXCL701 Gains Fast Track Designation for mCRPC Treatment
February 13th 2024The FDA has granted fast track designation to BXCL701 with an immune checkpoint inhibitor for metastatic small cell neuroendocrine prostate cancer resistant to chemotherapy and showing no evidence of microsatellite instability.
EP. 25: FDA Approves sBLA for Reduced Teclistamab Dose in R/R Multiple Myeloma
February 21st 2024The reduced dosing frequency of 1.5 mg/kg every 2 weeks for teclistamab in relapsed/refractory multiple myeloma who have sustained a complete response or better for at least 6 months provides flexibility in dosing schedules for patients.
EP. 29: FDA Approves IND Application of IMC001 for EpCAM+ Gastrointestinal Tumors
February 26th 2024The FDA has granted an investigational new drug application to the investigational chimeric antigen receptor T-cell therapy IMC001 for the treatment of EpCAM-positive advanced gastrointestinal tumors.
EP. 31: FDA Grants Priority Review to Epcoritamab for R/R Follicular Lymphoma
February 27th 2024If FDA-approved, epcoritamab would be the first and only subcutaneous bispecific antibody indicated for the treatment of adult patients with relapsed/refractory follicular lymphoma after 2 rounds of previous therapy.
EP. 33: FDA Revokes Melphalan Flufenamide Approval, Citing Efficacy/Safety Concerns
February 27th 2024Approval for melphalan flufenamide has been withdrawn by the FDA due to the failure of its confirmatory trial to demonstrate its clinical benefit and the lack of evidence supporting its safety and effectiveness.