Aliqopa (copanlisib) was given accelerated approval by the FDA in 2017 as a third-line treatment for adults with relapsed FL, a form of non-Hodgkin lymphoma (NHL), based on response rate data from the phase 2 CHRONOS-1 study.
The CHRONOS-4 trial intended to show that the drug extended progression-free survival (PFS) when added to stand chemotherapy for patients with relapsed FL and other forms of NHL, including marginal zone lymphoma (MZL) and lymphoplasmacytic lymphoma/Waldenström macroglobulinemia after at least one prior line of systemic therapy, but missed the mark.