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Notizie AIOM – anno XVII

13 Febbraio 2019

Dasatinib Approved in EU for Pediatric Ph+ ALL

February 11, 2019 - The European Commission has approved dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL), according to Bristol-Myers Squibb, the ...
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12 Febbraio 2019

New safety features for medicines sold in the EU

February 8, 2019 - As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. ...
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11 Febbraio 2019

EMA launches checklist to facilitate validation for initial marketing authorisation applications

February 8, 2019 - A survey launched by EMA in September 2016 shows that validation issues occur in 90% of initial marketing authorisation applications (MAAs). They create additional workload for companies and potential delays at a critical moment for the timely start of ...
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8 Febbraio 2019

Statement From American Society of Clinical Oncology (ASCO) President Monica M. Bertagnolli, MD, FACS, FASCO, on New Findings on Obesity and Cancer

February 4, 2019 - "Rates of obesity-related cancers are rising most sharply among young adults, but this study should serve as a wake-up call to all Americans - young and old alike - that obesity is linked to an increased risk of common cancers. If current trends continue, ...
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8 Febbraio 2019

American Lung Association’s State of Tobacco Control Report Released

February 5, 2019 - According to the American Lung Association’s recently released 2019 State of Tobacco Control report, states and the federal government have not taken meaningful action in establishing policies to prevent and reduce tobacco use, the nation's leading ...
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8 Febbraio 2019

FDA Approval Sought for Adjuvant T-DM1 in High-Risk HER2+ Breast Cancer

February 5, 2019 - Genentech (Roche) has completed its FDA submission of a supplemental Biologics License Application (sBLA) for ado-trastuzumab emtansine (T-DM1) as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following ...
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8 Febbraio 2019

FDA Approves Caplacizumab-yhdp in Acquired Thrombotic Thrombocytopenic Purpura

February 6, 2019 - The FDA has approved the nanobody caplacizumab-yhdp in combination with plasma exchange and immunosuppression for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), making it the first FDA-approved therapy indicated ...
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8 Febbraio 2019

FDA Extends Review Period for Ruxolitinib in GVHD

February 7, 2019 - The FDA has added 3 months to the review period for a supplemental new drug application (sNDA) for ruxolitinib for the treatment of patients with acute graft-versus-host disease (aGVHD) who have had an inadequate response to corticosteroids, making the ...
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8 Febbraio 2019

EU Panel Recommends Pembrolizumab/Chemo Combo in Squamous NSCLC

February 4, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for first-line treatment with pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel in patients with ...
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8 Febbraio 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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