domenica, 3 maggio 2026

Notizie AIOM – anno XV

16 Ottobre 2017

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. Retrospective cohort study. Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 ...
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16 Ottobre 2017

Brentuximab Vedotin Granted FDA Breakthrough Therapy Designation in Front-Line Advanced Hodgkin Lymphoma

October 9, 2017 - On October 2, Seattle Genetics, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to brentuximab vedotin in combination with chemotherapy for the front-line treatment of patients with advanced classical ...
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16 Ottobre 2017

FDA Approval Sought for Apalutamide in Prostate Cancer

October 11, 2017 - A new drug application (NDA) has been submitted to the FDA for apalutamide (ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor ...
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16 Ottobre 2017

Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma

Nivolumab and ipilimumab are immune checkpoint inhibitors that have been approved for the treatment of advanced melanoma. In the United States, ipilimumab has also been approved as adjuvant therapy for melanoma on the basis of recurrence-free and overall survival rates that ...
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13 Ottobre 2017

Osimertinib Receives Breakthrough Therapy Designation for NSCLC in First-Line

October 9, 2017 - The FDA has awarded Breakthrough Therapy Designation to osimertinib for first-line treatment of patients with metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC). Osimertinib is a third-generation, irreversible EGFR tyrosine kinase inhibitor ...
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13 Ottobre 2017

Lo screening può salvarti la vita!

Cittadinanzattiva lancia una campagna informativa digital sui principali social network, con hashtag #nonaspettare, di supporto al programma nazionale di screening per il cancro alla mammella, al colon retto e alla cervice uterina. Obiettivo è quello di raggiungere ...
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13 Ottobre 2017

New AML Drugs Approved and Under Investigation in 2017

October 9, 2017 - After nearly 40 years with little in the way of drug development for the treatment of acute myeloid leukemia (AML), four new drugs have been approved by the US Food and Drug Administration (FDA) in 2017 for AML, and several promising agents are in development. ...
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13 Ottobre 2017

FDA Approval Sought for Maintenance Rucaparib in Ovarian Cancer

October 10, 2017 - A supplemental new drug application (sNDA) has been submitted to the FDA for rucaparib as maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based ...
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13 Ottobre 2017

FDA Issues Complete Response Letter for Pegfilgrastim Biosimilar

October 10, 2017 - Biocon has announced that the FDA has issued a complete response letter (CRL) for Mylan’s biologics License Application (BLA) for MYL-1401H, a proposed biosimilar for Amgen’s pegfilgrastim. The company issued a statement reporting that the ...
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13 Ottobre 2017

FDA Grants Gilteritinib Fast Track Designation for AML

October 11, 2017 - The FDA has granted Fast Track designation to gilteritinib for adult patients with FLT3 mutation-positive relapsed/refractory acute myeloid leukemia (AML), according to Tokyo-based Astellas Pharma. Gilteritinib is an investigational compound that has demonstrated ...
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