lunedì, 17 agosto 2026

Notizie AIOM – anno XV n. 641

5 Settembre 2017

FDA approves Gemtuzumab Ozogamicin for treatment of acute myeloid leukemia

September 1, 2017 - The U.S. Food and Drug Administration today approved gemtuzumab ozogamicin for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved gemtuzumab ozogamicin for ...
Leggi tutto

5 Settembre 2017

FDA clears mammography device with option for patient-assisted compression

September 1, 2017 - Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken. "Regular mammograms are ...
Leggi tutto

5 Settembre 2017

FDA Grants LN-144 Fast Track Status for Melanoma

September 1, 2017 - The FDA has granted LN-144, an adoptive cell therapy that uses tumor-infiltrating lymphocyte (TIL) technology developed by Iovance Biotherapeutics, a fast track designation for the treatment of patients with advanced melanoma. The designation is based ...
Leggi tutto

5 Settembre 2017

Role of Cytotoxic Tumor-Infiltrating Lymphocytes in Predicting Outcomes in Metastatic HER2-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial

Accumulating evidence indicates that tumor-infiltrating lymphocytes (TILs) are associated with clinical outcomes and may predict the efficacy of chemotherapy and human epidermal growth factor receptor 2 (HER2, encoded by the gene ERBB2)-targeted therapy in patients with ...
Leggi tutto

5 Settembre 2017

1 settembre 2017 – Comunicazione EMA su paracetamolo a rilascio modificato

5 Settembre 2017

1 settembre 2017 – Pubblicazione schede di monitoraggio Registro Obinutuzumab

5 Settembre 2017

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

1 Settembre 2017

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

1 Settembre 2017

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

1 Settembre 2017

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