mercoledì, 12 agosto 2026

Notizie AIOM – anno XVI n. 699

20 Novembre 2018

FDA Approves Brentuximab Vedotin for Frontline CD30+ PTCL

November 16, 2018 - The FDA has approved brentuximab vedotin for use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma (PTCL). The approval, which follows a breakthrough therapy designation, is based ...
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20 Novembre 2018

FDA Grants Olaparib Priority Review for Frontline Maintenance in Ovarian Cancer

November 12, 2018 - The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for olaparib tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial ...
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20 Novembre 2018

FDA Grants Atezolizumab Combo Priority Review for Frontline TNBC

November 13, 2018 - The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive ...
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20 Novembre 2018

FDA Approves Frontline Eltrombopag for Severe Aplastic Anemia

November 16, 2018 - The FDA has expanded the approval of eltrombopag in combination with standard immunosuppressive therapy (IST) to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia (SAA), according to Novartis, the manufacturer ...
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19 Novembre 2018

FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More

November 14, 2018 - The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar. The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv. The biosimilar has been approved ...
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19 Novembre 2018

Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics

November 16, 2018 - EMA has reviewed serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented ...
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19 Novembre 2018

Blinatumomab Approaches European Approval for MRD+ ALL

November 16, 2018 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of blinatumomab for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but ...
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19 Novembre 2018

Nivolumab/Ipilimumab Combo Nears EU Approval for Frontline RCC

November 16, 2018 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of nivolumab combined with low-dose ipilimumab as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell ...
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19 Novembre 2018

Artificial-Intelligence Smartphone App Significantly Reduced Severity of Cancer Patients’ Pain and Hospital Admissions

November 13, 2018 - A study of 112 people with metastatic solid tumors found that the use of an artificial intelligence (AI)-based smartphone app reduced both the severity of patients’ reported pain and hospital admissions. After an eight-week period, patients who ...
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19 Novembre 2018

Side Effects From Certain Immunotherapies May Be Higher Than Initially Reported

November 13, 2018 - An analysis of nearly 2,800 people with non-small cell lung cancer (NSCLC) who received the immune checkpoint inhibitors nivolumab, pembrolizumab, or atezolizumab found that unexpected medical problems, known as adverse events, may be more common than ...
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