Shots:

• The BT designation is based on P-Ib KEYNOTE-524/Study 116 trial assessing Keytruda (200mg- IV- q3w) + Lenvima (12mg/day for patients weighing ≥60kg- and 8mg/day for patients weighing <60kg) in patients with unresectable HCC not amenable to locoregional treatment
• The FDA’s BT designation intended to expedite development and review of medicines for serious or life-threatening conditions
• This marks the third BT designation for the combination therapy. The first two BT designation for dual regimen was in advanced/m-RCC & advanced/ m-non- MSI-H/ pMMR endometrial carcinoma- received in Jan’2018 & July’2018 respectively

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Ref: Merck | Image: Merck