Richard Pazdur

TL;DR: Benefits and risks associated with 20 US Food and Drug Administration decisions associated with a set of candidate treatments submitted between 2003 and 2015 were analyzed and FDA approval decision outcomes considered were found to be consistent with the benefit–risk logic.

TL;DR: The expansion of the indication to patients with exposure to 2 prior TKIs was approved given data showing that ponatinib could be successfully used for the treatment of this population with appropriate monitoring and screening for risk factors.

TL;DR: The Bloomberg New Economy International Cancer Coalition brings together academia, industry, government, patient advocacy and policy think tanks to leverage technology and collaboration to improve patient access to clinical trials and to harmonize regulations aiming to accelerate cancer cures and prevention worldwide in the post-pandemic era as mentioned in this paper .

TL;DR: In its first year, the Oncology Center of Excellence conducted the clinical reviews for several products, including the first 2 chimeric antigen receptor T-cell therapies approved for the treatment of advanced hematologic malignancies and an in vitro diagnostic next-generation sequencing panel, FoundationOne CDx.