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Notizie AIOM – anno XVI n. 691

25 Settembre 2018

Hyperprogressive Disease in Patients With Advanced Non–Small Cell Lung Cancer Treated With PD-1/PD-L1 Inhibitors or With Single-Agent Chemotherapy

Hyperprogressive disease (HPD) is a new pattern of progression recently described in patients with cancer treated with programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors. The rate and outcome of HPD in advanced non–small cell lung ...
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24 Settembre 2018

ASCO Endorses AUA/ASTRO/SUO Guideline on Clinically Localized Prostate Cancer

September 20, 2018 - As reported in the Journal of Clinical Oncology by Justin E. Bekelman, MD, of the University of Pennsylvania Perelman School of Medicine, and colleagues, ASCO has endorsed the 2017 American Urological Association (AUA), American Society for Radiation ...
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24 Settembre 2018

FDA Takes New Steps to Address Youth E-Cigarette Use

September 17, 2018 - The U.S. Food and Drug Administration (FDA) has announced a series of critical and historic enforcement actions related to the sale and marketing of e-cigarettes to children. In the largest coordinated enforcement effort in the its history, the agency ...
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24 Settembre 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids

September 18, 2018 - In recent days, I’ve warned about an epidemic of use of e-cigarettes among teens. We’re in possession of data that shows a disturbingly sharp rise in the number of teens using e-cigarettes in just the last year. And none of the other metrics ...
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24 Settembre 2018

FDA Approval Sought for Erdafitinib in Urothelial Carcinoma

September 19, 2018 - A new drug application (NDA) has been submitted to the FDA for erdafitinib for the treatment of patients with locally advanced or metastatic urothelial carcinoma and FGFR genetic alterations whose tumors progressed following chemotherapy, according to ...
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24 Settembre 2018

FDA Accepts sBLA for Pembrolizumab Monotherapy in First-Line Treatment of Locally Advanced or Metastatic PD-L1–Expressing NSCLC

September 20, 2018 - The U.S. Food and Drug Administration (FDA) granted Priority Review to a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or ...
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24 Settembre 2018

EMA’s Committee for Medicinal Products for Human Use (CHMP) elects new chair

September 18, 2018 - At its September 2018 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) elected Harald Enzmann from Germany as its new chair, for a three-year mandate starting in October 2018. Dr Enzmann will ...
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24 Settembre 2018

Binimetinib/Encorafenib Combo Approved in Europe for BRAF+ Melanoma

September 20, 2018 - The European Commission has approved the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib for the treatment of adult patients with BRAF V600–mutant unresectable or metastatic melanoma, according to Array BioPharma, ...
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24 Settembre 2018

EU Panel Grants Positive Opinion to Brigatinib for ALK+ NSCLC

September 21, 2018 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended full approval of brigatinib as a treatment for patients with advanced ALK-positive non–small cell lung cancer (NSCLC) who are previously treated ...
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24 Settembre 2018

EU Panel Backs Venetoclax/Rituximab Combo in Relapsed/Refractory CLL

September 21, 2018 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is supporting the approval of venetoclax in combination with rituximab for patients with chronic lymphocytic leukemia (CLL) who have received at least 1 previous ...
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