Bayer Reports sNDA Submission to US FDA and MAA to EMA for Copanlisib + Rituximab to Treat B-iNHL and Relapsed MZL

 Bayer Reports sNDA Submission to US FDA and MAA to EMA for Copanlisib + Rituximab to Treat B-iNHL and Relapsed MZL

Bayer Reports sNDA Submission to US FDA and MAA to EMA for Copanlisib + Rituximab to Treat B-iNHL and Relapsed MZL

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

Click here to­ read full press release/ article | Ref: Bayer | Image: Business Standard

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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