Tags : aTTP

Chugai’s Rozlytrek Receives MHLW’s Approval for ROS1 Fusion-Positive Non-Small Cell

Shots: The approval is based on P-II STARTRK-2 study assessing the efficacy of Rozyltrek in ROS1 fusion-positive NSCLC cohort while the safety is evaluated in two P-I studies (STARTRK-1 study and ALKA-372-001 study) Additionally, Chugai receives MHLW’s approval for Alecensa (alectinib hydrochloride) and Rituxan to treat r/r ALK-positive ALCL) and ATTP respectively Rozlytrek is an […]Read More

Sanofi’s Cablivi (caplacizumab-yhdp) Receives FDA’s Approval for Acquired Thrombotic Thrombocytopenic

Shots: The approval is based on P-III HERCULES study results assessing Cablivi + plasma exchange and immunosuppressive therapy vs PBO (plasma exchange and immunosuppressive therapy) in 145 adults with aTTP P-III study results: reduction on a composite endpoint of aTTP-related death (12.7% vs 49.3%); aTTP recurrences (13% vs 38%); no deaths reported Cablivi (caplacizumab-yhdp) is […]Read More

Sanofi’s Cablivi Receives EU Marketing Approval for the Treatment of

Shots: The approval is based on P-II TITAN and P-III HERCULES studies enrolling 220 adults assessing Cablivi (caplacizumab) vs PBO, testing its safety and efficacy P-III HERCULES results:  significantly shorter time to platelet count response, reduction in aTTP-related death, lower number of aTTPrecurrence, meaningful reduction in use of plasma exchange (PEX) compared to PBO Cablivi […]Read More