Notizie AIOM – anno XVI n. 686
Binimetinib/Encorafenib Combo Approaches European Approval for BRAF+ Melanoma
July 27, 2018 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib for the treatment of adult patients with BRAF V600–mutant ...Leggi tutto
EU Panel Backs Frontline Daratumumab/VMP Combo for Multiple Myeloma
July 27, 2018 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of daratumumab in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple ...Leggi tutto
Adjuvant Dabrafenib/Trametinib Nears European Approval for BRAF+ Melanoma
July 27, 2018 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the combination of dabrafenib and trametinib for the adjuvant treatment of adult patients with BRAF V600E– or V600K–positive ...Leggi tutto
Durvalumab Approaches EU Approval for Locally Advanced PD-L1+ NSCLC
July 27, 2018 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of durvalumab for the treatment of patients with locally advanced, unresectable stage III non–small cell lung cancer (NSCLC) who have ...Leggi tutto
EMA restricts use of prostate cancer medicine Radium-223 dichloride
July 27, 2018 - The European Medicines Agency (EMA) has concluded its review of the cancer medicine radium-223 dichloride, and has recommended restricting its use to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread ...Leggi tutto
Phase 3, randomised trial of avelumab versus physician’s choice of chemotherapy as third-line treatment for patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300
There currently are no internationally recognised treatment guidelines for patients with advanced gastric cancer/gastro-oesophageal junction cancer (GC/GEJC) in whom two prior lines of therapy have failed. The randomised, phase 3 JAVELIN Gastric 300 trial compared avelumab ...Leggi tutto
FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer
July 24, 2018 - The U.S. Food and Drug Administration today approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System (Sentimag System) uses magnetic detection ...Leggi tutto