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FDA actions in brief, priority review, breakthrough designations, orphan drug designations
Ceftazidime-avibactam (Avycaz, Forest) antibacterial was approved to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
Panobinostat (Farydak, Novartis Pharmaceuticals) was approved for the treatment of patients with multiple myeloma.
Expanded indication for lenalidomide (Revlimid, Celgene) in combination with dexamethasone was approved to include patients newly diagnosed with multiple myeloma.
A supplemental New Drug Application was approved for rufinamide (Banzel, Eisai) as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients from aged 1 to 4 years old.
Lenvatinib (Lenvima, Eisai) was approved for the treatment of progressive, differentiated thyroid cancer.
TissuGlu Surgical Adhesive (Cohera Medical Inc.) was approved for internal use.
Palbociclib (Ibrance, Pfizer) was approved to treat metastatic breast cancer
MPDL3280A (Roche) cancer immunotherapy antibody for treating non-small cell lung cancer.
LentiGlobin BB305 (bluebird bio) for the treatment of transfusion-dependent patients with beta-thalassemia major.
Sirolimus (Rapamune, Pfizer) for the treatment of lymphangioleiomyomatosis, a rare lung disease.
LCZ696 (Novartis) for the treatment of heart failure patients with a reduced ejection fraction (HFrEF).
Nivolumab (Opdivo, Bristol-Myers Squibb) for use in patients with previously treated, advanced, squamous non–small cell lung cancer (NSCLC).
Trabectedin (Yondelis, Janssen) for treatment of patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
Cannabidiol (CBD) (Insys Therapeutics) formulation for the treatment of Dravet syndrome, a rare form of childhood epilepsy.
PBI-4050 (ProMetic Life Sciences) anti-fibrotic for the treatment of idiopathic pulmonary fibrosis.
Pelareorep (Reolysin, Oncolytics Biotech) for the treatment of pancreatic cancer.
Entrectinib (Ignyta) for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer.
Saposin C (Bexion Pharmaceuticals), the active ingredient in its proprietary drug BXQ-350 for the potential treatment of glioblastoma multiforme.