martedì, 5 maggio 2026

Notizie AIOM – anno XV

ASCO Announces CancerLinQ Partnerships With the FDA and the NCI

June 2, 2017 - CancerLinQ®, ASCO’s big data initiative to rapidly improve the quality of cancer care, is partnering with the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to study the real-world use of newly approved cancer treatments ...
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FDA Grants Adjuvant Sunitinib Priority Review in High-Risk RCC

June 1, 2017 - The FDA has granted a priority review designation to sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma (RCC) who have received nephrectomy and are high risk for recurrence. The supplemental new drug application for sunitinib is ...
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FDA Grants Priority Review to CPX-351 for AML

June 1, 2017 - The FDA has accepted a new drug application (NDA) from Jazz Pharmaceuticals, granting priority review to the company’s novel CPX-351 injection for acute myeloid leukemia (AML). CPX-351 is an investigational nano-scale liposome co-formulation of cytarabine ...
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Web-app

Una nuova web-app gratuita, in otto lingue, per computer, tablet e smartphone sul melanoma è disponibile sul sito del Corriere della Sera in collaborazione con l'Associazione Italiana di Oncologia Medica (leggi e scarica). Strumento interattivo in due versioni, per ...
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ASCO and CAP Invite Comment on Focused Update to HER2 Testing Guideline in Breast Cancer

May 25, 2017 - Draft recommendations as part of a focused update to the ASCO/College of American Pathologists (CAP) evidence-based guideline for human epidermal growth factor receptor 2 (HER2) testing in breast cancer are now open for public comment through June 12, 2017. ...
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FDA Panel Supports Neratinib Approval for HER2+ Breast Cancer

May 24, 2017 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-4 recommending approval of neratinib for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab. ODAC based its recommendation ...
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FDA Grants Priority Review to KTE-C19 for Non-Hodgkin Lymphoma

May 26, 2017 - The FDA has granted a priority review to axicabtagene ciloleucel (KTE-C19; axi-cel) for transplant-ineligible patients with relapsed or refractory non-Hodgkin lymphoma (NHL), according to Kite Pharma, the developer of the CD19-directed chimeric antigen receptor ...
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Follow-up of elderly patients with urogenital cancers: Evaluation of geriatric care needs and related actions

To investigate a comprehensive geriatric assessment (CGA) with subsequent investigation of healthcare patterns in older patients with urological cancers undergoing initial surgery or radiotherapy, to verify the usefulness of the incorporation of geriatric principles in future ...
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ODAC Recommends Approval of Epoetin Alfa Biosimilar

May 25, 2017 - The FDA’s Oncologic Drugs Committee voted (ODAC) 14-1 today to recommend approving a biologics license application (BLA) for epoetin hospira, an epoetin alfa biosimilar manufactured by Hospira. The BLA will now go to the FDA for consideration. The agency ...
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FDA Approves Ceritinib for Frontline ALK+ NSCLC

May 26, 2017 - The FDA has approved ceritinib for the treatment of patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), according to Novartis, the manufacturer of the second-generation ALK inhibitor. Patients’ ALK-positive status must be ...
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