Notizie AIOM – anno XV
Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update
To update the ASCO guideline for antiemetics in oncology. ASCO convened an Expert Panel and conducted a systematic review of the medical literature for the period of November 2009 to June 2016. Forty-one publications were included in this systematic review. A phase III randomized ...Leggi tutto
FDA Approves Frontline Fulvestrant for HR-Positive/HER2-Negative Breast Cancer
August 28, 2017 - The FDA has approved fulvestrant for use in hormone receptor (HR)-positive, HER2-negative locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. The approval is based on results from the phase ...Leggi tutto
FDA Grants Frontline Obinutuzumab Priority Review for Follicular Lymphoma
August 28, 2017 - The FDA has granted a priority review to a supplemental biologics license application (sBLA) for obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone, for the first-line treatment of patients with follicular lymphoma, according ...Leggi tutto
FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer
August 29, 2017 - The investigational HER2-targeting antibody-drug conjugate DS-8201 has received an FDA breakthrough therapy designation for the treatment of patients with HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab ...Leggi tutto
FDA approval brings first gene therapy to the United States
August 30, 2017 - The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved tisagenlecleucel ...Leggi tutto
FDA Delays Decision on Trastuzumab Biosimilar MYL-1401O
August 30, 2017 - The FDA has extended its decision deadline by 3 months on a biologics license application (BLA) for MYL-1401O, a trastuzumab biosimilar co-developed by Mylan and Biocon. Under the new timeframe, a final decision is expected on or before December 3, 2017. ...Leggi tutto
FDA Accepts sNDA for Carfilzomib Label Update in Myeloma
August 31, 2017 - The FDA has accepted a supplemental new drug application (sNDA) seeking to add overall survival (OS) data from the phase III ENDEAVOR trial to the label for carfilzomib for use in patients with relapsed or refractory multiple myeloma. Results from the primary ...Leggi tutto
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
August 31, 2017 - Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening disease. It is an exciting time for medical innovation. Already, clinical trials have helped realize exciting and meaningful ...Leggi tutto