Tags : EU

Regulatory

Bayer Reports sNDA Submission to US FDA and MAA to

Shots: The submissions are based on P-III CHRONOS-3 trial evaluating copanlisib + rituximab vs PBO + rituximab in patients with relapsed iNHL in extending PFS, following at least one prior rituximab-containing therapy Results: improvement in 1EPs of PFS, AEs of the combination was generally consistent with previously published data on the individual components of the […]Read More

Regulatory

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval

Shots: The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with unresectable/m-HER2+ BC prior treated with trastuzumab emtansine Results: @median follow up of 20.5mos., ORR (61.4%); CRR (54.9%); mDoR (20.8mos.). The safety of therapy has been evaluated in a pooled analysis […]Read More