Breyanzi Approved as Second-Line Treatment for Large B-Cell Lymphoma
The expanded approval was based on data from the phase 3 TRANSFORM and phase 2 PILOT studies.
Oncology
Tafinlar-Mekinist Combo Wins Tumor-Agnostic Indication for BRAF V600E Solid Tumors
The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
Vaccine Candidate Gets Orphan Drug Status for Glioblastoma Treatment
VBI-1901 is an investigational bivalent eVLP vaccine immunotherapeutic candidate designed to target 2 highly immunogenic CMV antigens, gB and pp65.
Topical Amitriptyline Gets Fast Track Status for Chemotherapy-Induced Neuropathic Pain
ATX01 is a topical formulation of amitriptyline designed to directly inhibit pain signaling in the nerve fibers on the epidermis and dermis.
FDA Withdraws Approval of Ukoniq Over Safety Concerns
Updated findings from the UNITY-CLL trial continue to show a possible increased risk of death among patients who received Ukoniq.
Kymriah Gets Accelerated Approval for Relapsed/Refractory Follicular Lymphoma
The accelerated approval for Kymriah was based on data from the phase 2 ELARA trial.
Tibsovo Approval Expanded for Newly Diagnosed IDH1-Mutated AML
The approval was based on data from the phase 3 AGILE trial.
Mirvetuximab Soravtansine Granted Priority Review for Ovarian Cancer
Mirvetuximab soravtansine is an antibody-drug conjugate comprised of a FRα-binding antibody, a cleavable linker, and a potent tubulin-targeting agent.
Trial Evaluating Tiragolumab Combo in PD-L1 High NSCLC Misses PFS Endpoint
The phase 3 study compared tiragolumab plus atezolizumab with placebo plus atezolizumab in adults with PD-L1 high locally advanced, unresectable or metastatic NSCLC.
FDA Clears Automated, Wearable 3D Breast Ultrasound Device
In 2 minutes, the portable ATUSA system automatically scans the entire breast volume and provides 3D visualization of the breast tissue.
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