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 combination with no new safety signals identified
• Bayer plans to seek additional filings globally based on the data from CHRONOS-3 study. Additionally- copanlisib has received ODD from FDA for CLL/SLL & LPL/WM and has previously granted an ODD in the US for FL and MZL

  | Ref: Bayer | Image: Business Standard