AstraZeneca’s Fasenra (benralizumab) hit a roadblock in attempting to expand the medicine’s indications when the U.S. Food and Drug Administration issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
In a Complete Response Letter to Biogen, the U.S. Food and Drug Administration said the regulatory agency is unable to approve the company’s supplemental Biologic License Application for subcutaneously delivered Tysabri (natalizumab) for the treatment of relapsing multiple sclerosis, at least while the sBLA remains in its present form.
The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.
FDA Rejects Merck’s 6-Week Dosing Schedule for Keytruda
Blockbusters, Checkpoint Inhibitors, Classical Hodgkin Lymphoma, Complete Response Letter, Dosing, FDA, FDA/Regulatory, Gastric Cancer, Hepatocellular Carcinoma, Melanoma, Merkel cell carcinoma, Primary Mediastinal B-Cell Lymphoma (PMBCL), Supplemental Biologics License Application (sBLA)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.
FDA Grants Priority Review to Genentech’s Tecentriq Monotherapy as First-line Treatment of Certain People With Advanced Non-small Cell Lung Cancer
ALK Mutations, Biomarkers, Blockbusters, EGFR Mutations, FDA, FDA/Regulatory, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Metastatic Squamous Non-Small Cell Lung Cancer, PD-1/PD-L1 inhibitors, Priority Review, Supplemental Biologics License Application (sBLA)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 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.
FDA Approves Eylea for Diabetic Retinopathy
Approvals, Diabetic Macular Edema, Diabetic Retinopathy, Diabetics, FDA, FDA/Regulatory, New Indications, Supplemental Biologics License Application (sBLA), Vascular Endothelial Growth Factor (VEGF) Inhibitors, Vision Loss, Wet Age-Related Macular DegenerationThe 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.
FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy for initial treatment of metastatic non-squamous non-small cell lung cancer
Blockbusters, FDA, FDA/Regulatory, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Supplemental Biologics License Application (sBLA), TherapeuticsRoche announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq in combination with Abraxane and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations.