The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Aliqopa ( Copanlisib ) for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.
Approval was based on efficacy results in 104 patients with relapsed follicular lymphoma enrolled in an open-label, single-arm, multicenter, phase 2 trial.
Patients received 0.8 mg/kg or 60 mg of Copanlisib by intravenous infusion on days 1, 8, and 15 of a 28-day treatment cycle.
The objective response rate was 58.7% ( 95% CI: 48.6-68.2% ) with an estimated median response duration of 12.2 months ( range, 0+ to 22.6 months ).
The complete response rate was 14.4% and partial response rate was 44.2%.
The safety population included 168 patients with follicular lymphoma and other hematologic malignancies treated with the recommended Copanlisib dosing regimen.
Common adverse reactions in greater than 20% of patients included hyperglycemia, diarrhea, fatigue, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, and thrombocytopenia.
The most common grade 3-4 adverse reactions included hyperglycemia, leukopenia, hypertension, neutropenia, and lower respiratory tract infections.
Serious non-infectious pneumonitis occurred in 6% of patients.
The recommended Copanlisib dose is 60 mg administered as a 1-hour intravenous infusion on days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule ( three weeks on and one week off ). ( Xagena )
Source: FDA, 2017