Notizie AIOM – anno XVII

17 Dicembre 2019

Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer

Patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer who have disease progression after therapy with multiple HER2-targeted agents have limited treatment options. Tucatinib is an investigational, oral, highly selective inhibitor ...
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17 Dicembre 2019

ASCO Congratulates Stephen M. Hahn, MD, FASTRO, on Confirmation as FDA Commissioner

December 12, 2019 - "The American Society of Clinical Oncology (ASCO) congratulates Stephen M. Hahn, MD, FASTRO, on his confirmation by the United States Senate to serve as the next Commissioner of the U.S. Food and Drug Administration (FDA). "An oncologist with more than ...
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17 Dicembre 2019

Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials

Entrectinib is a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, which has been shown to have anti-tumour activity against NTRK gene fusion-positive solid tumours, including CNS activity due to its ability to penetrate the blood–brain barrier. We ...
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16 Dicembre 2019

13 dicembre 2019 – Attivazione web e pubblicazione schede di monitoraggio – Registro Abemaciclib (Eli Lilly)

16 Dicembre 2019

13 dicembre 2019 – Attivazione web e pubblicazione schede di monitoraggio – Registro Venetoclax (AbbVie) (est.)

16 Dicembre 2019

13 dicembre 2019 – Aggiornamento modalità di gestione delle richieste di accesso al Fondo nazionale AIFA

16 Dicembre 2019

Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Olanzapine 10 mg added to standard antiemetic therapy including aprepitant, palonosetron, and dexamethasone has been recommended for the prevention of chemotherapy-induced nausea and vomiting. Guidelines suggest that a dose reduction to 5 mg should be considered to prevent ...
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13 Dicembre 2019

FDA Approves Generic Everolimus Tablets

December 10, 2019 - The FDA has approved 2 abbreviated new drug applications (ANDAs) for everolimus tablets for the treatment of patients with advanced hormone receptor–positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; progressive ...
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13 Dicembre 2019

FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

December 11, 2019 - The U.S. Food and Drug Administration today posted a warning letter to Alkermes, Inc. of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated ...
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13 Dicembre 2019

How will pharmacovigilance look in 2030?

December 10, 2019 - Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcare professionals will be key elements of pharmacovigilance ...
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Notizie AIOM – anno XVII

Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer

ASCO Congratulates Stephen M. Hahn, MD, FASTRO, on Confirmation as FDA Commissioner

Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials

13 dicembre 2019 – Attivazione web e pubblicazione schede di monitoraggio – Registro Abemaciclib (Eli Lilly)

13 dicembre 2019 – Attivazione web e pubblicazione schede di monitoraggio – Registro Venetoclax (AbbVie) (est.)

13 dicembre 2019 – Aggiornamento modalità di gestione delle richieste di accesso al Fondo nazionale AIFA

Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

FDA Approves Generic Everolimus Tablets

FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

How will pharmacovigilance look in 2030?