MorphoSys AG announced that the U.S. Food and Drug Administration accepted filing of MorphoSys’ Biologics License Application (BLA) and granted priority review for tafasitamab, the company’s investigational anti-CD19 antibody, under review in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).
Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.
Roche Group member Genentech announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.
The U.S. Food and Drug Administration’s busy schedule for drug reviews includes six supplemental BLAs for Merck’s blockbuster oncology brand Keytruda.
The U.S. Food and Drug Administration granted a priority review for GlaxoSmithKline plc’s Biologics License Application seeking approval of belantamab mafodotin (GSK2857916) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
The U.S. Food and Drug Administration accepted for filing Immunomedics Inc.’s Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease, as a complete class 2 response.
GlaxoSmithKline submitted a Biologics License Application to the U.S. FDA based upon results from the pivotal DREAMM-2 Phase III trial of belantamab mafodotin in multiple myeloma.
The U.S. Food and Drug Administration approved Allergan plc’s supplemental biologics application for Botox for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity.
The U.S. FDA approved Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) Injection for all stages of diabetic retinopathy, which is the leading cause of vision loss in diabetic patients.
Celgene and developmental partner Acceleron Pharma are eying a potential U.S. FDA approval of a blood-disease treatment.