FDA's Advisory Meetings（6月4日）
公開日時 2012/06/07 04:00
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Advisory Committee |
Date |
| Arena Pharmaceuticals’ lorcaserin as an adjunct to diet and exercise for weight management in patients with a BMI ≥30 kg/m2 or ≥27 kg/m2 if accompanied by weight-related comorbidities |
Endocrinologic and Metabolic Drugs |
10-May |
| Gilead Sciences’ “Quad” combination tablet containing elvitegravir, cobicistat, emtricitabine and tenofovir, for treatment of HIV-1 in antiretroviral-naïve adults |
Antiviral Drugs |
11-May |
| Janssen's Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine |
Cardiovascular and Renal Drugs |
23-May |
| Pfizer's Vyndaqel (tafamidis meglumine) to treat transthyretin familial amyloid polyneuropathy |
Peripheral and Central Nervous System Drugs |
24-May |
| Sanofi-Aventis' semuloparin for prophylaxis of venous thromboembolism in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk of 3 or greater |
Oncologic Drugs |
20-Jun |
| Onyx Pharmaceuticals' Kyprolis (carfilzomib) for relapsed and refractory multiple myeloma in patients who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent |
Oncologic Drugs |
20-Jun |
| Recent research on communicating and understanding uncertainty, and risk perception and information seeking when facing multiple risks |
Risk Communication |
29-Jun |
| GSK's Tykerb (lapatinib) in combination with trastuzumab for metastatic breast cancer patients whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s); evaluation of radiographic review in randomized clinical trials using progression-free survival as a primary endpoint in non-hematologic malignancies |
Oncologic Drugs |
24-Jul |
| Whether pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information |
Oncologic Drugs |
25-Jul
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