venerdì, 9 ottobre 2026

Notizie AIOM – anno XVI n. 665

Adjuvant vemurafenib in resected, BRAFV600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial

Systemic adjuvant treatment might mitigate the high risk of disease recurrence in patients with resected stage IIC-III melanoma. The BRIM8 study evaluated adjuvant vemurafenib monotherapy in patients with resected, BRAFV600 mutation-positive melanoma. BRIM8 was a phase 3, ...
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Liquid Biopsy Tests in People with Cancer: An Expert Review

March 1, 2018 - Use of tests that assess genomic variants in circulating tumor DNA (ctDNA) is on the rise. A new joint review from the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) provides an assessment of evidence on ctDNA ...
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FDA Grants Fast Track Designation to Pamrevlumab in Locally Advanced Unresectable Pancreatic Cancer

March 2, 2018 - On March 1, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the anti–connective tissue growth factor (CTGF) antibody pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer. This ...
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2 marzo 2018 – Richiamo sulle modalità di presentazione della domanda di autorizzazione degli emendamenti sostanziali alla sperimentazione clinica

26 febbraio 2018 – FDA estende le indicazioni terapeutiche di Durvalumab

Safety and Clinical Activity of Pembrolizumab and Multisite Stereotactic Body Radiotherapy in Patients With Advanced Solid Tumors

Stereotactic body radiotherapy (SBRT) may stimulate innate and adaptive immunity to augment immunotherapy response. Multisite SBRT is an emerging paradigm for treating metastatic disease. Anti-PD-1–treatment outcomes may be improved with lower disease burden. In this ...
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FDA Approves Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer

February 26, 2018 - The FDA has approved abemaciclib for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and ...
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FDA Grants Orphan Drug Designation to YS-ON-001 for the Treatment of Pancreatic Cancer

February 27, 2018 - On February 26, Yisheng Biopharma Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to its lead immuno-oncology candidate, YS-ON-001, for the treatment of pancreatic cancer. YS-ON-001 is a clinical-stage ...
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FDA Accepts BLA for Calaspargase Pegol in Acute Lymphoblastic Leukemia

March 1, 2018 - On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component ...
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Towards more ethical use of animals in medicine testing

February 26, 2018 - The European Medicines Agency (EMA) has published today its first report summarising the Agency’s actions carried out by two of its committees in 2016 and 2017 – the Committee for Medicinal Products for Human Use (CHMP) and the Committee for ...
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