Notizie AIOM – anno XVII n. 745

12 Novembre 2019

FDA Approval Sought for Ibrutinib/Rituximab in Frontline CLL/SLL

November 8, 2019 - A supplemental new drug application (sNDA) has been submitted to the FDA for ibrutinib for use in combination with rituximab for the first-line treatment of patients ≤70 years old with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma ...
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12 Novembre 2019

FDA approves first therapy to treat patients with rare blood disorder

November 8, 2019 - Today the U.S. Food and Drug Administration granted approval to luspatercept–aamt for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. “When patients ...
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8 Novembre 2019

ASCO Congratulates Stephen M. Hahn, MD, FASTRO, on Nomination to Serve as FDA Commissioner

November 1, 2019 - Based on strong findings for efficacy and safety, as well as FDA approvals, the Society for Immunotherapy of Cancer (SITC) has issued the first guidelines for the use of immunotherapy agents in patients with recurrent or metastatic (RM) head and neck squamous ...
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8 Novembre 2019

Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices

November 6, 2019 - Public health and safety is the highest priority at the U.S. Food and Drug Administration. We maintain a robust practice of postmarket surveillance and risk evaluation programs to identify new adverse events that did not appear during the product development ...
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8 Novembre 2019

Quality of life analysis in lung cancer: a systematic review of phase III trials published between 2012 and 2018

We previously reported that quality of life (QoL) is not included among trial endpoints and QoL results are underreported in a significant proportion of phase III oncology trials. Here we describe QoL adoption, reporting and methodology of QoL analysis in lung cancer trials. ...
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8 Novembre 2019

Indirect Comparisons of Efficacy between Combination Approaches in Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis

There have been substantial changes in the management of men with metastatic hormone-sensitive prostate cancer (mHSPC) over the past 5 yr, with upfront combination therapies replacing androgen-deprivation therapy (ADT) alone. A range of therapies have entered the space ...
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8 Novembre 2019

Final results of a prospective study of scalp cooling in preventing chemotherapy-induced alopecia

Alopecia is a distressing effect of cancer treatments. Our study examined efficacy and safety of scalp cooling to prevent chemotherapy-induced alopecia. Early breast cancer patients candidate to anthracycline and/or taxane were eligible. Dean's alopecia scale was used to ...
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8 Novembre 2019

4 novembre 2019 – Chiusura Managed Entry Agreements (MEA) Registro Brentuximab vedotin (Takeda)

8 Novembre 2019

5 novembre 2019 – Vitamina D – chiarimenti sulla Nota 96

8 Novembre 2019

7 novembre 2019 – Domenico Mantoan nuovo Presidente del CdA dell’Agenzia Italiana del Farmaco

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FOSSC: “BENE FINALMENTE L’ARRIVO DEI NUOVI LIVELLI ESSENZIALI D’ASSISTENZA DOPO BEN 9 ANNI DI ATTESA MA ORA SERVE CON RAPIDITA’ UN ULTERIORE AGGIORNAMENTO PER COPRIRE GLI ULTIMI 3 ANNI DI ACQUISIZIONE DI TRATTAMENTI INNOVATIVI”

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Notizie AIOM – anno XVII n. 745

FDA Approval Sought for Ibrutinib/Rituximab in Frontline CLL/SLL

FDA approves first therapy to treat patients with rare blood disorder

ASCO Congratulates Stephen M. Hahn, MD, FASTRO, on Nomination to Serve as FDA Commissioner

Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices

Quality of life analysis in lung cancer: a systematic review of phase III trials published between 2012 and 2018

Indirect Comparisons of Efficacy between Combination Approaches in Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis

Final results of a prospective study of scalp cooling in preventing chemotherapy-induced alopecia

4 novembre 2019 – Chiusura Managed Entry Agreements (MEA) Registro Brentuximab vedotin (Takeda)

5 novembre 2019 – Vitamina D – chiarimenti sulla Nota 96

7 novembre 2019 – Domenico Mantoan nuovo Presidente del CdA dell’Agenzia Italiana del Farmaco