Merck and Eisai’s Dual Regimen Receives the US FDA’s Breakthrough Therapy Designation as 1L Treatment for Advanced Unresectable Hepatocellular Carcinoma

 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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Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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