venerdì, 31 marzo 2023

Notizie AIOM – anno XVI n. 668

Lenvatinib Approved for HCC in Japan

March 23, 2018 - Japan’s Pharmaceuticals and Medical Devices Agency has approved lenvatinib mesylate for the frontline treatment of patients with unresectable hepatocellular carcinoma (HCC). The approval was based on data from the phase III REFLECT trial, in which ...
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Trastuzumab Biosimilar Approaches European Approval

March 23, 2018 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of ABP 980, a biosimilar to trastuzumab. If the European Commission now follows the CHMP recommendation, ...
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NCCN Recommends TTFields With Temozolomide for Newly Diagnosed GBM

March 20, 2018 - The NCCN has added the combination of TTFields and temozolomide to its guidelines for Category 1 treatment of newly diagnosed glioblastoma following maximal safe resection and completion of radiation therapy. TTFields is an antimitotic treatment modality ...
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FDA expands approval of Brentuximab Vedotin for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

March 20, 2018 - The U.S. Food and Drug Administration today approved brentuximab vedotin to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. “Today’s approval represents an improvement ...
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FDA Approves Nilotinib for Pediatric CML

March 22, 2018 - The FDA has approved nilotinib for the first- and second-line treatment of pediatric patients aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). The approval was issued based on a ...
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FDA Updates Public Information About Known Risk of Lymphoma From Breast Implants

March 23, 2018 - On March 21, the U.S. Food and Drug Administration (FDA) issued updated information about its understanding of breast implant–associated anaplastic large cell lymphoma (ALCL). The agency is providing an updated number of medical device reports (ie, ...
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018

March 23, 2018 - The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting. The CHMP recommended granting a conditional marketing authorisation ...
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Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma

Nivolumab plus ipilimumab produced objective responses in patients with advanced renal-cell carcinoma in a pilot study. This phase 3 trial compared nivolumab plus ipilimumab with sunitinib for previously untreated clear-cell advanced renal-cell carcinoma. We randomly assigned ...
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Safety and Antitumor Activity of Pembrolizumab in Patients with Estrogen Receptor‒Positive/Human Epidermal Growth Factor Receptor 2‒Negative Advanced Breast Cancer

We investigated the safety and antitumor activity of the anti-programmed death 1 monoclonal antibody pembrolizumab in patients with estrogen receptor‒positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer with programmed death ...
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Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study

Immune checkpoint inhibitors are a new standard of care for patients with advanced non-small-cell lung cancer (NSCLC) without EGFR tyrosine kinase or anaplastic lymphoma kinase (ALK) genetic aberrations (EGFR−/ALK−), but clinical benefit in patients with EGFR ...
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