Web Exclusives

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.
Last November, osimertinib (Tagrisso), a third-generation EGFR tyrosine kinase inhibitor (TKI) that targets EGFR mutations, including T790M, was approved by the US Food and Drug Administration (FDA) for the treatment of patients with metastaticEGFR T790M mutation–positive non–small-cell lung cancer (NSCLC) whose disease progressed during or after EGFR TKI therapy.
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.
On April 11, 2016, the FDA approved venetoclax (Venclexta), the first-in-class BCL-2 inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) and 17p deletion who received ≥1 previous therapies.
In this response, Roy and colleagues explain the model’s rationale, noting that its overall objective was to provide a framework for future use.
Inflectra is approved for several indications, similar to its originator, including severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis.
On March 30, 2016, the US Food and Drug Administration (FDA) approved defibrotide sodium (Defitelio; Jazz Pharmaceuticals) for the treatment of children and adult patients with hepatic veno-occlusive disease plus kidney or lung abnormalities after hematopoietic stem-cell transplantation. This is the first drug to be approved by the FDA for patients with severe hepatic veno-occlusive disease.
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