venerdì, 16 ottobre 2026

Notizie AIOM – anno XIV n. 608

2 Dicembre 2016

Ixazomib Granted Conditional European Approval for Myeloma

The European Commission has granted a conditional approval to ixazomib (Ninlaro) in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma following at least 1 prior therapy, based on a near 6-month improvement in progression-free survival ...
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2 Dicembre 2016

Reaffirming and Clarifying the American Society of Clinical Oncology’s Policy Statement on the Critical Role of Phase I Trials in Cancer Research and Treatment

On behalf of ASCO, we thank Dr Jonathan Kimmelman for highlighting a number of important issues in the design and conduct of phase I clinical trials in oncology. The ethics surrounding cancer phase I trials have been an important topic of discussion throughout the modern ...
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2 Dicembre 2016

Effect of Tailored Dose-Dense Chemotherapy vs Standard 3-Weekly Adjuvant Chemotherapy on Recurrence-Free Survival Among Women With High-Risk Early Breast Cancer A Randomized Clinical Trial

Standard dosing of chemotherapy based on body surface area results in marked interpatient variation in pharmacokinetics, toxic effects, and efficacy. Whether tailored dosing can improve outcomes is unknown, as is the role of dose-dense adjuvant chemotherapy. To determine ...
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2 Dicembre 2016

Androgen Deprivation Therapy and the Risk of Dementia in Patients With Prostate Cancer

Recent observational studies have associated the use of androgen deprivation therapy (ADT) with an increased risk of dementia and Alzheimer’s disease, but these studies had limitations. The objective of this study was to determine whether the use of ADT is associated ...
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2 Dicembre 2016

FDA Grants Priority Review to Pembrolizumab for New Indication in Microsatellite Instability–High Cancer

On November 28, the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for the treatment of previously treated patients with advanced microsatellite instability–high (MSI-H) ...
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2 Dicembre 2016

ASCO Releases Criteria for High-Quality Clinical Pathways in Oncology

ASCO today released Criteria for High-Quality Clinical Pathways in Oncology, a set of 15 inter-related criteria that provide an overarching framework for assessing pathway programs in the United States. ASCO developed the criteria to guide stakeholders in assessing the quality, ...
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2 Dicembre 2016

FDA Grants Full Approval and Label Update for Ponatinib in CML and ALL

The U.S. Food and Drug Administration (FDA) has granted ponatinib (Iclusig) full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic ...
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2 Dicembre 2016

FDA Grants Priority Review to Avelumab for Merkel Cell Carcinoma

The FDA has granted a priority review to a biologics license application (BLA) for avelumab as a treatment for patients with metastatic Merkel cell carcinoma (MCC), according to a statement from Merck KGaA and Pfizer, the codevelopers of the PD-L1 inhibitor. The priority ...
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2 Dicembre 2016

Impact of Radiation Therapy on Aggressive Care and Quality of Life near Death

Radiation therapy (RT) is used with palliative intent in patients with advanced stage cancer. Prior studies, primarily in patients with poor performance status (PS), suggest that RT is associated with aggressive medical care, which may impact patients’ quality of life ...
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2 Dicembre 2016

Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

Niraparib is an oral poly(adenosine diphosphate -ribose) polymerase (PARP) 1/2 inhibitor that has shown clinical activity in patients with ovarian cancer. We sought to evaluate the efficacy of niraparib versus placebo as maintenance treatment for patients with platinum-sensitive, ...
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