Bayer's Copanlisib Receives Priority Review Status from US FDA

Bayer has announced that the US Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies.

Copanlisib is an intravenous pan-class I phosphatidylinositol- 3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-a and PI3K-d isoforms. FL is the most common subtype of indolent non-Hodgkin's lymphoma (iNHL).

The FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions, when compared to standard applications. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months (compared to 10 months under standard review).

The regulatory submission for copanlisib is based on data from the Phase II open-label, single-arm study CHRONOS-1 evaluating patients with relapsed or refractory indolent Non-Hodgkin's Lymphoma (iNHL). The full analysis set comprised 142 patients, of which 141 patients had iNHL. At the time of analysis, median duration of treatment was 22 weeks and 46 patients remained on treatment. The results across all patient groups show an objective response rate (ORR) of 59.2%, with a 12% complete response (CR) rate, and a median duration of response (DOR) of more than 98 weeks (687 days).