FDA News & Updates
December 2016 Vol 9, Special Issue: Payers’ Perspectives In Oncology: AVBCC 2016 Highlights - FDA News & Updates
- Bevacizumab Approved for Platinum-Sensitive Ovarian Cancer in Combination with Chemotherapy
- Daratumumab Approved in Combination with Standard Regimen for Multiple Myeloma
- Nivolumab Now Approved for Head and Neck Squamous-Cell Carcinoma
On September 23, 2016, the FDA approved adalimumab-atto (Amjevita; Amgen) as a biosimilar to adalimumab (Humira; AbbVie) for the treatment of several indications and inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; moderate-to-severe Crohn’s disease; moderate-to-severe ulcerative colitis; and moderate-to-severe plaque psoriasis.
The FDA approved a first-of-its-kind device, Medtronic’s MiniMed 670G hybrid closed looped system, that will automatically monitor glucose and provide basal insulin doses in patients aged ≥14 years with type 1 diabetes. The MiniMed 670G hybrid closed looped system acts as an artificial pancreas, with little or no input needed from the user.
On April 29, 2016, the US Food and Drug Administration (FDA) approved pimavanserin (Nuplazid; Acadia), an atypical antipsychotic, for the treatment of hallucinations and delusions associated with Parkinson’s disease. Pimavanserin is the first drug approved by the FDA for hallucinations and delusions that are associated with Parkinson’s disease.
On May 27, 2016, the US Food and Drug Administration approved daclizumab (Zinbryta; Biogen), a long-acting injection, for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab can be self-administered by the patient. Daclizumab is recommended for patients who had an inadequate response to ≥2 drugs for MS, because of its safety profile.
On June 1, 2016, Netspot became the first US Food and Drug Administration–approved kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor–positive neuroendocrine tumors.
On June 1, 2016, the US Food and Drug Administration (FDA) approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in patients with NSCLC.
On May 18, 2016, the US Food and Drug Administration (FDA) approved atezolizumab (Tecentriq; Genentech) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
ProAir RespiClick (Albuterol Sulfate): First Breath-Actuated Inhaler Approved for the Treatment or Prevention of Bronchospasm
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