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FDA's Advisory Meetings(7月2日)

公開日時 2012/07/05 04:00

Topic
Advisory Committee Date
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(ies) Oncologic Drugs July 24 (a.m.)
Evaluation of radiographic review in randomized clinical trials using progression-free survival as a primary endpoint in non-hematologic malignancies Oncologic Drugs July 24 (p.m.)
Whether pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information Oncologic Drugs 25-Jul
Genentech's Lucentis (ranibizumab) for diabetic macular edema Dermatologic and Ophthalmic Drugs July 26 (a.m.)
ThromboGenics' Jetrea (ocriplasmin intravitreal injection) for symptomatic vitreomacular adhesions including macular hole Dermatologic and Ophthalmic Drugs July 26 (p.m.)

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