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The accelerated approval was granted based on initial overall response rate (ORR) of 57% in 164 treatment-naïve patients and duration of response (DOR)—40% of responders had a duration of response greater than 12 months, according to the FDA’s full approval announcement
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(2010) Evaluation of the human prediction of clearance from hepatocyte and microsome intrinsic clearance for 52 drug compounds Xenobiotica 40(9)
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