Bayer’s Aliqopa (copanlisib) Receives the US FDA’s Breakthrough Therapy Designation to Treat Marginal Zone Lymphoma in Adults

Bayer Plans Two P-III Studies to Evaluate Aflibercept 8mg Formulation


  • The BT Designation is based on the P-II CHRONOS-1 study which involves assessing of 25 patients with relapsed or refractory MZL who have received at least two prior therapies
  • The study resulted in ORR of overall iNHL population (n=142) was 59.2%, while the MZL patients (23%), @18 mos. ORR (60.6% and 78.3%) in FAS population and MZL histology
  • Aliqopa is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity against PI3K-α and PI3K-δ isoforms expressed in malignant B cells. Additionally, Bayer is conducting two P-III studies CHRONOS-3 and CHRONOS-4 evaluating the safety and efficacy of Aliqopa

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