Roshni Ramchandani

TL;DR: In patients with imatinib refractory or intolerant GIST, time-to-tumor progression of sunitinib-treated patients was superior to that of placebo- treated patients, and in patients with metastatic renal cell carcinoma, partial responses were observed.

TL;DR: The Food and Drug Administration review supporting the approval of dasatinib for CML and Ph+ ALL is described based on the rates and durability of cytogenetic and hematologic responses.

TL;DR: The survival model and the tumor model will be beneficial for early screening of candidate drugs, simulating NSCLC trials, and optimizing trial designs.

TL;DR: Assessment of the role of pharmacometrics at the US Food and Drug Administration in making drug approval and labeling decisions finds the need for early interaction between the FDA and sponsors to plan the development more efficiently by appreciating the regulatory expectations better.

TL;DR: Nilotinib prolongs the QT interval and sudden deaths have been reported; these risks and appropriate risk minimization strategies are described in a boxed warning on the labeling.