domenica, 3 maggio 2026

Notizie AIOM – anno XVII

1 Febbraio 2019

FDA Recommends No NDA for Tivozanib in RCC

January 31, 2019 - The FDA has recommended that Aveo Oncology should not submit a new drug application (NDA) for tivozanib with the preliminary overall survival (OS) data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell ...
Leggi tutto

1 Febbraio 2019

Public consultation on key principles for the electronic product information of EU medicines

January 31, 2019 - EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching today a six-month public consultation on draft key principles which will form the basis on which the electronic product information (ePI) for human medicines will ...
Leggi tutto

1 Febbraio 2019

Randomized Phase 1 Trial of Pembrolizumab with Sequential Versus Concomitant Stereotactic Body Radiotherapy in Metastatic Urothelial Carcinoma

Preclinical data indicate that radiotherapy works synergistically with pembrolizumab, but the effect and toxicity of this combination may depend on radiotherapy timing. We conducted a randomized phase 1 trial combining pembrolizumab with either sequential (A) or concomitant ...
Leggi tutto

29 Gennaio 2019

FDA, EMA Recommend Against Starting Olaratumab for Soft Tissue Sarcoma

January 24, 2019 - The FDA has recommended that no new patients with advanced soft tissue sarcoma (STS) should be treated with the combination of olaratumab plus doxorubicin, following the negative results of the phase III ANNOUNCE trial. The agency's statement follows the ...
Leggi tutto

25 Gennaio 2019

FDA Approval Sought for Daratumumab/Rd for Frontline Transplant-Ineligible Myeloma

January 22, 2019 - A supplemental Biologics License Application (sBLA) has been initiated with the FDA for daratumumab for use in combination with lenalidomide and dexamethasone (DRd) for the treatment of newly diagnosed patients with multiple myeloma who are not candidates ...
Leggi tutto

25 Gennaio 2019

FDA Grants Umbralisib Breakthrough Designation for Marginal Zone Lymphoma

January 22, 2019 - The FDA has granted umbralisib (TGR-1202) a breakthrough therapy designation for the treatment of adult patients with marginal zone lymphoma (MZL) who have received 1 prior anti-CD20 regimen, according to TG Therapeutics, Inc., the developer of the PI3K-delta ...
Leggi tutto

25 Gennaio 2019

FDA Approves 23andMe Consumer Test for Hereditary CRC Syndrome

January 23, 2019 - The FDA has cleared a direct-to-consumer genetic test for a risk report on MUTYH-associated polyposis, a hereditary colorectal cancer (CRC) syndrome, announced 23andMe, the personal genetics company that manufactures the test. The approval will allow the ...
Leggi tutto

25 Gennaio 2019

BMS Withdraws Application for Nivolumab/Ipilimumab in TMB-High NSCLC

January 24, 2019 - Bristol-Myers Squibb (BMS) has withdrawn its supplemental biologics license application (sBLA) for the combination of nivolumab and ipilimumab for the frontline treatment of patients with advanced non–small cell lung cancer (NSCLC) with tumor mutational ...
Leggi tutto

25 Gennaio 2019

European Commission Approves Maintenance Rucaparib in Ovarian Cancer

January 24, 2019 - The European Commission has approved an expanded indication for single-agent rucaparib as a maintenance therapy in adult patients with platinum-sensitive, relapsed, high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in ...
Leggi tutto

25 Gennaio 2019

PROREPAIR-B: A Prospective Cohort Study of the Impact of Germline DNA Repair Mutations on the Outcomes of Patients With Metastatic Castration-Resistant Prostate Cancer

Germline mutations in DNA damage repair (DDR) genes are identified in a significant proportion of patients with metastatic prostate cancer, but the clinical implications of these genes remain unclear. This prospective multicenter cohort study evaluated the prevalence and ...
Leggi tutto