martedì, 5 maggio 2026

Notizie AIOM – anno XV

FDA Grants Frontline Alectinib Priority Review for ALK-Positive NSCLC

August 3, 2017 - The FDA has granted a priority review to a supplemental new drug application (sNDA) for alectinib for the frontline treatment of patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC), according to Genentech (Roche), ...
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EU Approval Sought for Axicabtagene Ciloleucel in Non-Hodgkin Lymphoma

July 31, 2017 - Kite Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel (axi-cel) to treat 3 forms of non-Hodgkin lymphoma (NHL). Axi-cel, an anti-CD19 chimeric antigen receptor (CAR) T cell ...
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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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FDA Approves Ipilimumab for Pediatric Melanoma

July 24, 2017 - The FDA has approved ipilimumab for the treatment of patients aged ≥12 years with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor. The expanded indication for ipilimumab is based ...
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Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer

Pertuzumab increases the rate of pathological complete response in the preoperative context and increases overall survival among patients with metastatic disease when it is added to trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor ...
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Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study

Metastatic DNA mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) colorectal cancer has a poor prognosis after treatment with conventional chemotherapy and exhibits high levels of tumour neoantigens, tumour-infiltrating lymphocytes, and checkpoint regulators. ...
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24 luglio 2017 – FDA approva un nuovo trattamento per ridurre il rischio di recidive del cancro al seno

Avelumab Recommended for EU Approval for Merkel Cell Carcinoma

July 21, 2017 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of avelumab for adults with metastatic Merkel cell carcinoma, according to Pfizer and Merck, the codevelopers of the PD-L1 inhibitor. The European ...
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EMA Panel Backs Approval of Lutetium [177Lu] oxodotreotide for GEP-NETs

July 21, 2017 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Lutetium oxodotreotide for the treatment of patients with unresectable or metastatic, progressive, well-differentiated (grade 1 and grade ...
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Frontline Obinutuzumab Recommended for EU Approval for Follicular Lymphoma

July 21, 2017 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of obinutuzumab in the frontline setting for the treatment of patients with follicular lymphoma, according to Roche, the manufacturer of the ...
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