Notizie AIOM – anno XVII
FDA Places Partial Hold on Cervical Cancer Trial of AIM2CERV
January 24, 2019 - The FDA has placed a partial clinical hold on the phase III AIM2CERV trial (NCT02853604) evaluating the use of axalimogene filolisbac in patients with high-risk locally advanced cervical cancer, according to Advaxis, Inc., the developer of the investigational ...Leggi tutto
Blinatumomab Approved in Europe for MRD+ ALL
January 22, 2019 - The European Commission has approved blinatumomab for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD) of at least 0.1%.The indication is specifically ...Leggi tutto
No new patients should start treatment with olaratumab after study shows cancer medicine does not prolong life
January 23, 2019 - Preliminary results from the ANNOUNCE study show that olaratumab in combination with doxorubicin is not more effective at prolonging the lives of patients with soft tissue cancer than doxorubicin alone. While full results from the study are awaited, EMA ...Leggi tutto
EMA relocation updates
January 23, 2019 - The European Medicines Agency (EMA) will physically relocate to the Netherlands in early March 2019. The Dutch authorities have already officially handed over the temporary building, the Spark building in Amsterdam Sloterdijk, to EMA’s Executive ...Leggi tutto
FDA Issues Complete Response Letter for Sacituzumab Govitecan in TNBC
January 18, 2019 - The FDA has issued a complete response letter to Immunomedics regarding its biologics license application (BLA) for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior ...Leggi tutto