Notizie AIOM – anno XV n. 611

10 Gennaio 2017

Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life

Early palliative care (EPC) in oncology has shown sparse evidence of a positive impact on patient outcomes, quality of care outcomes and costs. Data for this secondary analysis were taken from a trial of 207 outpatients with metastatic pancreatic cancer randomly assigned ...
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10 Gennaio 2017

Trastuzumab Emtansine With or Without Pertuzumab Versus Trastuzumab Plus Taxane for Human Epidermal Growth Factor Receptor 2–Positive, Advanced Breast Cancer: Primary Results From the Phase III MARIANNE Study

Trastuzumab and pertuzumab are human epidermal growth factor receptor 2 (HER2)–targeted monoclonal antibodies, and trastuzumab emtansine (T-DM1) is an antibody–drug conjugate that combines the properties of trastuzumab with the cytotoxic activity of DM1. T-DM1 ...
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10 Gennaio 2017

Rovalpituzumab tesirine, a DLL3-targeted antibody-drug conjugate, in recurrent small-cell lung cancer: a first-in-human, first-in-class, open-label, phase 1 study

Rovalpituzumab tesirine is a first-in-class antibody-drug conjugate directed against delta-like protein 3 (DLL3), a novel target identified in tumour-initiating cells and expressed in more than 80% of patients with small-cell lung cancer. We aimed to assess the safety and ...
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9 Gennaio 2017

FDA Grants Priority Review for the sNDA for Regorafenib in the Second-Line Systemic Treatment of Liver Cancer

5 gennaio 2017 - On January 4, the U.S. Food and Drug Administration (FDA) granted Priority Review status for the supplemental New Drug Application (sNDA) for regorafenib (Stivarga) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma ...
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9 Gennaio 2017

FDA Grants JCAR017 Breakthrough Designation for Non-Hodgkin Lymphoma

21 dicembre 2016 - JCAR017 has received an FDA breakthrough therapy designation for the treatment of patients with relapsed/refractory, aggressive large B-cell non-Hodgkin lymphoma (NHL), according to Juno and Celgene, the codevelopers of the CD19-targeted CAR T-cell therapy. ...
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9 Gennaio 2017

FDA Lifts Clinical Hold on Pacritinib

5 gennaio 2017 - The FDA has lifted its clinical hold on trials exploring pacritinib, according to CTI BioPharma, the developer of the JAK2/FLT3 inhibitor. In February 2016, the FDA placed a full clinical hold on pacritinib studies following reports of patient deaths related ...
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9 Gennaio 2017

Optimal timing of influenza vaccination during 3-week cytotoxic chemotherapy cycles

Cytopenia occurs frequently during cytotoxic chemotherapy. Little is known about the optimal timing of influenza vaccination for patients receiving chemotherapy. This study compared the immunogenicity of an influenza vaccine administered concurrently with chemotherapy (day ...
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9 Gennaio 2017

FDA Permits Marketing of New Tissue Expander for Women Undergoing Breast Reconstruction Following Mastectomy

22 dicembre 2016 - On December 21, the U.S. Food and Drug Administration (FDA) allowed marketing of a new tissue-expander system for soft-tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft-tissue ...
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9 Gennaio 2017

FDA Grants Priority Review to sNDA for Full Approval of Palbociclib in Breast Cancer

21 dicembre 2016 - The FDA has granted a priority review to a supplemental new drug application (sNDA) supporting the conversion of the accelerated approval of palbociclib (Ibrance) to a full approval for use in combination with letrozole as a frontline treatment for postmenopausal ...
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9 Gennaio 2017

FDA Issues Complete Response Letter for Lutathera in Neuroendocrine Tumors

23 dicembre 2016 - The FDA has issued a complete response letter (CRL) to Advanced Accelerator Applications informing the company that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine ...
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LAVORIAMO CON

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Notizie AIOM – anno XV n. 611

Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life

Trastuzumab Emtansine With or Without Pertuzumab Versus Trastuzumab Plus Taxane for Human Epidermal Growth Factor Receptor 2–Positive, Advanced Breast Cancer: Primary Results From the Phase III MARIANNE Study

Rovalpituzumab tesirine, a DLL3-targeted antibody-drug conjugate, in recurrent small-cell lung cancer: a first-in-human, first-in-class, open-label, phase 1 study

FDA Grants Priority Review for the sNDA for Regorafenib in the Second-Line Systemic Treatment of Liver Cancer

FDA Grants JCAR017 Breakthrough Designation for Non-Hodgkin Lymphoma

FDA Lifts Clinical Hold on Pacritinib

Optimal timing of influenza vaccination during 3-week cytotoxic chemotherapy cycles

FDA Permits Marketing of New Tissue Expander for Women Undergoing Breast Reconstruction Following Mastectomy

FDA Grants Priority Review to sNDA for Full Approval of Palbociclib in Breast Cancer

FDA Issues Complete Response Letter for Lutathera in Neuroendocrine Tumors