FDA Passes on Poziotinib for HER2 Exon 20 Insertion Mutation-Positive NSCLC
According to the CRL, the application could not be approved in its present form as additional data, including a randomized controlled trial, would be required.
Oncology
Epcoritamab Granted Priority Review for Relapsed/Refractory Large B-Cell Lymphoma
Epcoritamab is designed to bind to CD3 on T cells and CD20 on B cells, inducing T cell mediated killing of CD20+ cells.
FDA Approves Additional Dosing Schedule for Rylaze
The MWF dosing option was approved under the Real-Time Oncology Review program based on data from the intramuscular administration part of a phase 2/3 trial.
Zejula Use for Second-Line Maintenance Treatment Restricted
The decision to restrict the indication follows an FDA review of the double-blind, placebo-controlled phase 3 ENGOT-OV16/NOVA trial.
Elahere Granted Accelerated Approval for Platinum-Resistant Ovarian Cancer
The approval was based on data from the SORAYA trial.
Adcetris Approved for Pediatric Patients With High-Risk Classical Hodgkin Lymphoma
The approval was based on data from the open-label phase 3 AHOD1331 trial.
Libtayo Plus Chemotherapy Approved as First-Line Treatment for Advanced NSCLC
Findings showed that treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in overall survival.
FDA Panel Votes Against Omburtamab Due to Multiple Efficacy Issues
Omburtamab is an investigational radiolabeled monoclonal antibody designed to target tumor cells that express B7-H3.
Sapanisertib Fast Tracked for NRF2-Mutated Squamous NSCLC
Sapanisertib is a dual mTORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells.
Rolvedon Now Available for Chemotherapy-Induced Neutropenia
Rolvedon is a long-acting granulocyte colony-stimulating factor.
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