Merck and Eisai’s Dual Regimen Receives the US FDA’s Breakthrough Therapy Designation as 1L Treatment for Advanced Unresectable Hepatocellular Carcinoma
Merck & Co. Reports Results of Keytruda (pembrolizumab) + CT in P-III KEYNOTE-355 Study as 1L Treatment for Metastatic Triple-Negative Breast Cancer
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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