The FDA has granted Priority Review for the New Drug Application of copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies.
Copanlisib is a pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. The efficacy and safety of copanlisib has not been established. The broad clinical development program for copanlisib also includes phase III studies in indolent non-Hodgkin lymphoma (NHL) patients who have relapsed or are refractory to prior therapies.
The regulatory submission for copanlisib is based on data from the phase II open-label, single-arm CHRONOS-1 study (NCT01660451) evaluating patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL). CHRONOS-1 was designed to evaluate the efficacy and safety of copanlisib in patients with relapsed or refractory indolent NHL, including FL, who received at least two prior therapies. The primary endpoint is the objective tumor response rate, with duration of response, overall survival, progression-free survival, quality-of-life, and safety serving as secondary endpoints.