mercoledì, 18 settembre 2024

Notizie AIOM – anno XVIII

Frontline Pembrolizumab Regimens Receive Japanese Approval in Head and Neck Cancer

December 20, 2019 - Japan’s Pharmaceuticals and Medical Devices Agency has granted approval to frontline pembrolizumab as monotherapy and in combination with chemotherapy for the treatment of patients with recurrent or distant metastatic head and neck cancer. ...
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Frontline Pembrolizumab/Axitinib Approved in Japan for Advanced RCC

December 20, 2019 - Japan’s Pharmaceuticals and Medical Devices Agency has approved the combination of pembrolizumab and axitinib for the first-line treatment of patients with radically unresectable or metastatic renal cell carcinoma (RCC). The approval is based on ...
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Everett E. Vokes, MD, FASCO, Elected ASCO President for 2021-2022 Term

December 17, 2019 - The American Society of Clinical Oncology (ASCO) has elected Everett E. Vokes, MD, FASCO, a long-time member and volunteer, to serve as its President for the term beginning in June 2021. He will take office as President-Elect during the ASCO Annual Meeting ...
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Ten Oncology Practices in Underserved Communities Receive Funding to Participate in Quality Improvement Programs

December 18, 2019 - Ten oncology practices from rural and urban centers in the U.S. that primarily treat underserved populations have received grant funding to participate in the American Society of Clinical Oncology’s (ASCO) Quality Oncology Practice Initiative (QOPI®) ...
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FDA Approval Sought for Ripretinib for Advanced GIST

December 16, 2019 - A new drug application (NDA) has been submitted to the FDA for ripretinib for use as a treatment for patients with advanced gastrointestinal stromal tumors (GIST) who have previously received treatment with imatinib, sunitinib, and regorafenib. The application ...
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FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer

December 17, 2019 - The FDA has approved a supplemental new drug application for enzalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer. The approval is based on findings from the phase III ARCHES trial, in which the median radiographic ...
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FDA Panel Backs Maintenance Olaparib for Metastatic Pancreatic Cancer

December 17, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 in favor of olaparib tablets for an indication as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma ...
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FDA Grants Ivosidenib Breakthrough Status for Relapsed/Refractory IDH1+ MDS

December 17, 2019 - The FDA has granted a breakthrough therapy designation to ivosidenib for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes (MDS) who harbor IDH1 mutations. The designation is based on results from an MDS substudy of a ...
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FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway

December 17, 2019 - The U.S. Food and Drug Administration today announced it has authorized the marketing of two new tobacco products manufactured by 22nd Century Group Inc. - Moonlight and Moonlight Menthol, which are combusted, filtered cigarettes that contain a reduced ...
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FDA Panel Supports Tazemetostat for Epithelioid Sarcoma

December 18, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11-0) in favor of approving tazemetostat tablets as a treatment for patients with metastatic or locally advanced epithelioid sarcoma that is ineligible for curative surgery. ...
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