lunedì, 4 maggio 2026

Notizie AIOM – anno XV

FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

March 27, 2017 - The U.S. Food and Drug Administration today approved niraparib for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely ...
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FDA Warning Links Breast Implants to ALCL

March 29, 2017 - Breast implants may increase an individual’s risk of developing anaplastic large cell lymphoma, a recent FDA advisory warned. The warning follows on a statement released by the FDA in 2011 suggesting a potential link between breast implants and the ...
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FDA Panel Supports Subcutaneous Rituximab for Blood Cancers

March 29, 2017 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) unanimously (11-0) recommended approval of subcutaneous rituximab for the treatment of patients with certain blood cancers, according to Genentech, the manufacturer of the treatment. The company explained ...
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FDA Grants Priority Review to sBLA for Full Approval of Blinatumomab in ALL

March 29, 2017 - The FDA has granted a priority review to a supplemental biologics license application (sBLA) supporting the conversion of the accelerated approval of blinatumomab to a full approval as a treatment for patients with Philadelphia chromosome-negative (Ph-) ...
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FDA Grants Full Approval to Osimertinib for T790M+ NSCLC

March 30, 2017 - The FDA has granted a regular approval to osimertinib as a treatment for patients with metastatic EGFR T790M mutation-positive non–small cell lung cancer (NSCLC) following prior treatment with an EGFR TKI, based on progression-free survival (PFS) findings ...
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Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial

A phase 2 trial suggested increased overall survival and increased incidence of treatment-related grade 3–4 adverse events with ipilimumab 10 mg/kg compared with ipilimumab 3 mg/kg in patients with advanced melanoma. We report a phase 3 trial comparing the benefit–risk ...
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HER2-enriched subtype as a predictor of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancer (PAMELA): an open-label, single-group, multicentre, phase 2 trial

HER2-positive breast cancer consists of four intrinsic molecular subtypes-luminal A, luminal B, HER2-enriched, and basal-like-and a normal-like subtype, with the HER2-enriched subtype having the highest activation of the EGFR-HER2 pathway. We aimed to test the hypothesis ...
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Prevalence of lymph node metastasis and prognostic significance of lymphadenectomy in apparent early-stage malignant ovarian sex cord-stromal tumors

The aim of this retrospective population-based study was to investigate the prevalence of lymph node metastasis in patients with apparent early stage malignant sex cord-stromal tumors (SCSTs) and the effect of regional lymph node sampling/lymphadenectomy (LND) on their survival. ...
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27 marzo 2017 – Comitato per i Medicinali per Uso umano (CHMP) dell’EMA: highlights del meeting di marzo

27 marzo 2017 – Comunicazione EMA su sospensione di medicinali a causa di studi non attendibili condotti da Micro Therapeutic Research Labs