martedì, 10 settembre 2024

Notizie AIOM – anno XVII n. 727

14 giugno 2019 – Comunicazione EMA su medicinali contenenti Leuprorelina

FDA Approves Fifth Trastuzumab Biosimilar

June 13, 2019 - The FDA has approved ABP 980 (trastuzumab-anns), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth ...
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2019

June 14, 2019 - EMA’s safety committee (PRAC) has started a review of leuprorelin medicines after reports indicated that handling errors during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the ...
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Resumption of Immune Checkpoint Inhibitor Therapy After Immune-Mediated Colitis

Immune checkpoint inhibitor (ICI) therapy often is suspended because of immune-mediated diarrhea and colitis (IMDC). We examined the rate of and risk factors for IMDC recurrence after ICI resumption. This retrospective multicenter study examined patients who resumed ICI ...
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FDA Approves Single-Agent Pembrolizumab or Plus Chemo for Frontline HNSCC

June 11, 2019 - The FDA has approved pembrolizumab for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma as monotherapy whose tumors express PD-L1 (composite positive score ≥1) or in combination with ...
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Two additional countries to benefit from EU-US mutual recognition agreement for inspections

June 11, 2019 - On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of these two additional EU ...
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Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer

Apalutamide is an inhibitor of the ligand-binding domain of the androgen receptor. Whether the addition of apalutamide to androgen-deprivation therapy (ADT) would prolong radiographic progression-free survival and overall survival as compared with placebo plus ADT among ...
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Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer

Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostate cancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival ...
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12 giugno 2019 – L’agenzia del farmaco finlandese ritiene possibile la sostituzione automatica dei biologici con i biosimilari, se attentamente pianificata e attuata gradualmente

12 giugno 2019 – In Germania prevista dal 2022 la sostituzione dei biosimilari nelle farmacie