giovedì, 13 agosto 2026

Notizie AIOM – anno XVII n. 706

21 Gennaio 2019

FDA Issues Complete Response Letter for Sacituzumab Govitecan in TNBC

January 18, 2019 - The FDA has issued a complete response letter to Immunomedics regarding its biologics license application (BLA) for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior ...
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21 Gennaio 2019

FDA Approves Third Trastuzumab Biosimilar

January 18, 2019 - The FDA has granted an approval to SB3 (trastuzumab-dttb), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma. The approval is based on data sets ...
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21 Gennaio 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

January 18, 2019 - At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update ...
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18 Gennaio 2019

FDA Accepts sBLA for Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel in Nonsquamous NSCLC

January 17, 2019 - The FDA has accepted a supplemental biologics license application (sBLA) for atezolizumab, carboplatin, and nab-paclitaxel as a first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC). The sBLA is based on ...
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18 Gennaio 2019

Tumor mutational load predicts survival after immunotherapy across multiple cancer types

Immune checkpoint inhibitor (ICI) treatments benefit some patients with metastatic cancers, but predictive biomarkers are needed. Findings in selected cancer types suggest that tumor mutational burden (TMB) may predict clinical response to ICI. To examine this association ...
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18 Gennaio 2019

Revised guideline aims to strengthen global approach to development of new antibacterial medicines

January 14, 2019 - EMA has published a revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections for a six-month public consultation. Stakeholders can send their comments by 31 July 2019 to idwpecretariat@ema.europa.eu ...
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18 Gennaio 2019

Nivolumab/Ipilimumab Combo Approved in Europe for Frontline RCC

January 15, 2019 - The European Commission has approved nivolumab combined with low-dose ipilimumab as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC), according to Bristol-Meyers Squibb (BMS), the developer of both ...
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18 Gennaio 2019

Acute malignant obstruction in patients with peritoneal carcinomatosis: The role of palliative surgery

Patients with peritoneal carcinomatosis who do not have curative treatment options often develop acute obstructive symptoms and when conservative management fails, surgical treatment is the remaining option. However, palliative surgery is associated with high morbidity and ...
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18 Gennaio 2019

Scheda informativa condivisa da ISS, PMA, AIMAC e AIOM

Suggerimenti semplici su come preservare la fertilità prima dei trattamenti antitumorali, firmate da Istituto Superiore di Sanità (ISS), Registro Nazionale di Procreazione Medicalmente Assistita (PMA), Associazione Italiana Malati di Cancro, parenti e amici ...
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18 Gennaio 2019

Dal Soroptimist International Club Genova a favore delle ragazze STEM

Il Premio, del valore di 2.000 Euro, sarà attribuito ad una Tesi di Laurea Magistrale in campo Emato-Oncologico, discussa da una studentessa dell’Università degli Studi di Genova negli anni accademici 2016-17 o 2017-18, in una delle seguenti discipline: ...
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