martedì, 5 maggio 2026

Notizie AIOM – anno XVII

EU Panel Backs Pembrolizumab Plus Axitinib for Frontline RCC

July 29, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of pembrolizumab in combination with axitinib for the frontline treatment of patients with advanced renal cell carcinoma (RCC). The CHMP based its ...
Leggi tutto

Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel Nears EU Approval in Nonsquamous NSCLC

July 29, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion to the triplet regimen of atezolizumab, carboplatin, and nab-paclitaxel for the first-line treatment of patients with advanced, nonsquamous ...
Leggi tutto

Names of liposomal medicines to be changed to avoid medication errors

July 31, 2019 - All marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit to EU regulators a variation to change the names of these medicines as soon as possible before the end of September 2019. This recommendation ...
Leggi tutto

NICE Approves Frontline Pembrolizumab Regimen for Squamous NSCLC

Aug 8, 2019 - The UK’s National Institute for Health and Care Excellence has authorized the use of pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the treatment of patients with metastatic squamous non–small cell lung ...
Leggi tutto

Ibrutinib EU Indications Expanded in CLL and Waldenstrom Macroglobulinemia

Aug 13, 2019 - The European Commission has expanded the approval of ibrutinib to include use in combination with obinutuzumab for adult patients with previously untreated chronic lymphocytic leukemia (CLL), and also in combination with rituximab for the treatment of adult ...
Leggi tutto

ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer

Enzalutamide, a potent androgen-receptor inhibitor, has demonstratedsignificant benefits in metastatic and nonmetastatic castration-resistant prostate cancer. We evaluated the efficacy and safety of enzalutamide inmetastatic hormone-sensitive prostate cancer (mHSPC). ARCHES ...
Leggi tutto

Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non–Small Cell Lung Cancer A Phase 2 Trial

Patients with oligometastatic non–small cell lung cancer (NSCLC) may benefit from locally ablative therapy (LAT) such as surgery or stereotactic radiotherapy. Prior studies were conducted before the advent of immunotherapy, and a strong biological rationale for the ...
Leggi tutto

The association between metformin and ovarian cancer survival: a systematic review and meta-analysis of cohort studies

A number of observational studies examined the association between metformin therapy and ovarian cancer survival outcomes, but the results are inconsistent. To investigate the effect of metformin on survival for ovarian cancer patients. PubMed, Embase and Web of Science ...
Leggi tutto

TAS-102 Nears EU Approval for Gastric Cancer

July 26, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed approval of TAS-102 (trifluridine/tipiracil) for the treatment of adult patients with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal ...
Leggi tutto

First ‘histology-independent’ treatment for solid tumours with a specific gene mutation

July 26, 2019 - EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for larotrectinib for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase ...
Leggi tutto