Tags : Hepatocellular Carcinoma

Medivir’s MIV-818 Receives EC’s Orphan Medicinal Product Designation to Treat

Shots: EMA has granted orphan medicinal product designation for the treatment of patients with hepatocellular carcinoma (HCC) Orphan Medicinal Product designation provides regulatory and financial incentives for companies to develop and market therapies treating life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 persons in the EU MIV-818 is a pro-drug designed […]Read More

Merck and Eisai’s Dual Regimen Receives the US FDA’s Breakthrough

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 […]Read More

Merck and Eisai’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive FDA’s

Shots: The third BT designation is based on P-Ib KEYNOTE-524 study assessing Keytruda (200mg, IV, q3w) + Lenvima (12/8 mg/day) in patients with unresectable HCC not amenable to locoregional treatment The dual regimen has received its first two BT designation for advanced and metastatic renal carcinoma and non-microsatellite instability-high/proficient mismatch repair endometrial carcinoma in Jan’18 […]Read More