martedì, 22 ottobre 2024

Notizie AIOM – anno XVI

28 dicembre 2017 – Rettifica: Carenza Busulfano – modalità di richiesta d’Importazione dall’estero

29 dicembre 2017 – 16° Rapporto Nazionale AIFA sulla Sperimentazione Clinica dei medicinali in Italia

2 gennaio 2018 – Epatite C: l’eradicazione in un percorso chiaro e progressivo

FDA Approves Frontline Cabozantinib for Advanced RCC

December 19, 2017 - The FDA has approved cabozantinib for previously untreated patients with advanced renal cell carcinoma (RCC), based on a meaningful improvement in progression-free survival (PFS) versus sunitinib in the CABOSUN trial. In the phase II study, first-line ...
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FDA Approves Bosutinib for Newly-Diagnosed Ph+ CML

December 19, 2017 - The FDA has approved bosutinib as a first-line treatment for patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), based on findings from the phase III BFORE trial. In the open-label study, the major molecular response (MMR) ...
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FDA Approves Adjuvant Nivolumab for Melanoma

December 20, 2017 - The FDA has approved nivolumab as an adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease, based on findings from the phase III CheckMate-238 trial. In the randomized trial, the recurrence-free ...
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FDA Grants Ribociclib Breakthrough Designation for HR+/HER2- Premenopausal Breast Cancer

January 3, 2018 - The FDA has granted ribociclib a breakthrough therapy designation for use in combination with tamoxifen or an aromatase inhibitor (AI) as frontline treatment for pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or ...
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FDA Approves Denosumab for Multiple Myeloma

January 5, 2018 - The FDA has approved denosumab for the prevention of skeletal-related events (SREs) in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor. The approval is based on data from the phase III 482 study, which were ...
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CHMP Issues Positive Opinion on CT-P6 for HER2+ Breast, Gastric Cancers

December 18, 2017 - The European Union’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion for CT-P6, a trastuzumab biosimilar, for the treatment of patients with HER2-positive early breast cancer, metastatic breast cancer, or metastatic ...
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NICE Recommends Ixazomib for Multiple Myeloma Through CDF

December 19, 2017 - The United Kingdom's National Institute for Health and Care Excellence (NICE) has issued guidance recommending ixazomib in for patients with relapsed/refractory multiple myeloma. The proteasome inhibitor developed by Takeda is indicated for use in combination ...
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