FDA has approved fluocinolone acetonide intravitreal implant (Iluvien, Alimera) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Iluvien was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.
Adding pertuzumab (Perjeta, Roche) to trastuzumab (Herceptin, Genentech) and docetaxel chemotherapy extended the lives (overall survival; OS) of people with previously untreated HER2-positive metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy (median OS: 56.5 vs. 40.8 months), according to data presented at the European Society for Medical Oncology 2014 congress in Madrid, Spain.
FDA approved methylnaltrexone bromide (Relistor, Salix Pharmaceuticals and Progenics Pharmaceuticals) subcutaneous injection, 12 mg/0.6 mL, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain.
An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug omalizumab (Xolair, Genentech) than in those who were not treated with omalizumab. As a result, FDA has added information about these potential risks to the drug label.
FDA has approved updated label changes for the smoking cessation drug, varenicline (Chantix, Pfizer).