venerdì, 31 marzo 2023

Notizie AIOM – anno XVI n. 669

30 marzo 2018 – Monitoraggio della Spesa Farmaceutica Nazionale e Regionale (gennaio / novembre 2017)

Intravesical recurrence after bladder sparing treatment of small cell carcinoma of the bladder: Characteristics, treatment, and outcome

Small cell carcinoma of the bladder (SCCB) is a rare and lethal disease. Previously, we and others have reported a bladder sparing strategy with platinum-etoposide-based chemotherapy followed by radiotherapy of the bladder. Little is known on frequency and treatment of intravesical ...
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Trastuzumab Deruxtecan Receives Expedited Review in Japan for Gastric Cancer

March 27, 2018 - Japanese regulators have granted a Sakigake designation to trastuzumab deruxtecan (DS-8201), for the treatment of patients with HER2-positive gastric cancer that is refractory to trastuzumab, according to Daiichi Sankyo, the manufacturer of the antibody-drug ...
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ASCO and ESMO Value Frameworks May Be Beneficial in Determining Best Maintenance Therapies for Ovarian Cancer

March 26, 2018 - In recent years, the Food and Drug Administration approved several maintenance therapies for the management of platinum-sensitive recurrent ovarian cancer. Clinical trials that led to these approvals involved bevacizumab, TKIs, or PARP inhibitors. To access ...
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FDA Grants Nivolumab/Ipilimumab Priority Review for MSI-H/dMMR Colorectal Cancer

March 27, 2018 - The FDA has granted a priority review to a supplemental biologics license application (sBLA) for the combination of nivolumab and ipilimumab for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ...
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EU recommendations for 2018/2019 seasonal flu vaccine composition

March 26, 2018 - The European Medicines Agency (EMA) has issued the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2018. Trivalent vaccines for ...
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Regulatory information – 1.7% increase of fees from 1 April 2018

March 28, 2018 - General, non-pharmacovigilance fees payable to the European Medicines Agency (EMA) by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2018. Full details of the new fee levels are available in Commission Regulation (EU) No ...
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Health-Related Quality-of-Life Analysis From KEYNOTE-045: A Phase III Study of Pembrolizumab Versus Chemotherapy for Previously Treated Advanced Urothelial Cancer

In the phase III KEYNOTE-045 study (ClinicalTrials.gov identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator’s choice of chemotherapy in patients with previously treated advanced urothelial cancer. Here, we report ...
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Long-term follow-up of overall survival for cabozantinib versus everolimus in advanced renal cell carcinoma

In the phase 3 METEOR trial (NCT01865747), cabozantinib significantly improved progression-free survival, overall survival, and objective response rate compared with everolimus in patients with advanced renal cell carcinoma (RCC) after prior antiangiogenic therapy. A statistically ...
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27 marzo 2018 – Registri AIFA: l’Agenzia fornisce informazioni sui dati dei trattamenti con i nuovi farmaci per la cura dell’epatite C