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Notizie Newsletter

10 Dicembre 2019

Hype or hope? The strange case of platinum salts’ renaissance in breast cancer

In the last decade, the clinical applicability of platinum salts in breast cancer (BC) has gained momentum, mainly in the context of homologous recombination-deficiency (HRD) where effects of DNA-damaging agents are particularly enhanced. Indeed, these agents have been traditionally ...
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9 Dicembre 2019

FDA Waives ODAC Review of Luspatercept in MDS

December 6, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting on December 18, 2019, will no longer include a session reviewing a supplemental Biologics License Application (sBLA) for luspatercept-aamt (Reblozyl) for use as a treatment for patients ...
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9 Dicembre 2019

UK Expands Olaparib Maintenance Indication in Ovarian Cancer

December 3, 2019 - The UK’s National Institute for Health and Care Excellence has approved olaparib for the maintenance treatment of adult patients with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer whose ...
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9 Dicembre 2019

EMA update on metformin diabetes medicines

December 6, 2019 - EMA is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the EU. The levels of NDMA in the affected non-EU metformin medicines are very low and appear to be ...
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9 Dicembre 2019

Olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B): a multicentre, open-label, randomised, phase 2 trial

Metastatic castration-resistant prostate cancer is enriched in DNA damage response (DDR) gene aberrations. The TOPARP-B trial aims to prospectively validate the association between DDR gene aberrations and response to olaparib in metastatic castration-resistant prostate ...
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9 Dicembre 2019

IMbrave150: Efficacy and safety results from a ph III study evaluating atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (Sor) as first treatment (tx) for patients (pts) with unresectable hepatocellular carcinoma (HCC)

Ph 1b data has shown promising efficacy and safety for atezo + bev in unresectable HCC pts who have not received prior systemic therapy. Here, we report the primary analysis data from the Ph 3 IMbrave150 trial comparing atezo + bev vs sor in this pt population. IMbrave150 ...
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6 Dicembre 2019

Olaparib Approved in China for Frontline Maintenance in Ovarian Cancer

December 5, 2019 - China’s National Medical Products Administration has granted marketing authorization for olaparib as a first-line maintenance treatment for adult patients with newly diagnosed advanced germline or somatic BRCA-mutated epithelial ovarian, fallopian ...
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6 Dicembre 2019

Sacituzumab Govitecan TNBC Application Resubmitted to FDA

December 3, 2019 - Immunomedics has resubmitted its biologics license application (BLA) to the FDA for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (TNBC) who have received ≥2 prior therapies for metastatic disease. ...
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6 Dicembre 2019

FDA Approves Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel for Nonsquamous NSCLC

December 4, 2019 - The FDA has approved atezolizumab in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) who do not harbor EGFR or ALK molecular aberrations. ...
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6 Dicembre 2019

FDA Approves FoundationOne CDx as a Companion Diagnostic for Alpelisib/Fulvestrant Treatment in Breast Cancer

December 5, 2019 - On December 4, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx to be used as a companion diagnostic for alpelisib in combination with fulvestrant for the treatment of postmenopausal female patients as well as male patients with hormone ...
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