mercoledì, 18 settembre 2024

Notizie AIOM – anno XVII n. 707

29 Gennaio 2019

FDA, EMA Recommend Against Starting Olaratumab for Soft Tissue Sarcoma

January 24, 2019 - The FDA has recommended that no new patients with advanced soft tissue sarcoma (STS) should be treated with the combination of olaratumab plus doxorubicin, following the negative results of the phase III ANNOUNCE trial. The agency's statement follows the ...
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25 Gennaio 2019

FDA Approval Sought for Daratumumab/Rd for Frontline Transplant-Ineligible Myeloma

January 22, 2019 - A supplemental Biologics License Application (sBLA) has been initiated with the FDA for daratumumab for use in combination with lenalidomide and dexamethasone (DRd) for the treatment of newly diagnosed patients with multiple myeloma who are not candidates ...
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25 Gennaio 2019

FDA Grants Umbralisib Breakthrough Designation for Marginal Zone Lymphoma

January 22, 2019 - The FDA has granted umbralisib (TGR-1202) a breakthrough therapy designation for the treatment of adult patients with marginal zone lymphoma (MZL) who have received 1 prior anti-CD20 regimen, according to TG Therapeutics, Inc., the developer of the PI3K-delta ...
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25 Gennaio 2019

FDA Approves 23andMe Consumer Test for Hereditary CRC Syndrome

January 23, 2019 - The FDA has cleared a direct-to-consumer genetic test for a risk report on MUTYH-associated polyposis, a hereditary colorectal cancer (CRC) syndrome, announced 23andMe, the personal genetics company that manufactures the test. The approval will allow the ...
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25 Gennaio 2019

BMS Withdraws Application for Nivolumab/Ipilimumab in TMB-High NSCLC

January 24, 2019 - Bristol-Myers Squibb (BMS) has withdrawn its supplemental biologics license application (sBLA) for the combination of nivolumab and ipilimumab for the frontline treatment of patients with advanced non–small cell lung cancer (NSCLC) with tumor mutational ...
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25 Gennaio 2019

European Commission Approves Maintenance Rucaparib in Ovarian Cancer

January 24, 2019 - The European Commission has approved an expanded indication for single-agent rucaparib as a maintenance therapy in adult patients with platinum-sensitive, relapsed, high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in ...
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25 Gennaio 2019

PROREPAIR-B: A Prospective Cohort Study of the Impact of Germline DNA Repair Mutations on the Outcomes of Patients With Metastatic Castration-Resistant Prostate Cancer

Germline mutations in DNA damage repair (DDR) genes are identified in a significant proportion of patients with metastatic prostate cancer, but the clinical implications of these genes remain unclear. This prospective multicenter cohort study evaluated the prevalence and ...
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25 Gennaio 2019

Association of Patient Comorbid Conditions With Cancer Clinical Trial Participation

The American Society of Clinical Oncology (ASCO), Friends of Cancer Research, and the US Food and Drug Administration recently recommended modernizing criteria related to comorbidities routinely used to exclude patients from cancer clinical trials. The goal was to design ...
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25 Gennaio 2019

Analysis of the Prevalence of Microsatellite Instability in Prostate Cancer and Response to Immune Checkpoint Blockade

The anti-programmed cell death protein 1 (PD-1) antibody pembrolizumab is approved by the US Food and Drug Administration for the treatment of microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors, but the prevalence of MSI-H/dMMR prostate ...
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25 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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