On September 24, 2018, the US FDA granted accelerated approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies.

IPI-145-08 Study

The multicenter, open-label single arm IPI-145-08 study (NCT02204982) enrolled 83 FL patients refractory to rituximab and to either chemotherapy or radioimmunotherapy. The overall response rate (ORR) by independent review committee (IRC) was 42% (35/83 [95% CI: 31–54]). Partial responses (PR) with duvelisib occurred in 41% of patients, one patient achieved a complete response (CR).

A response duration of at least 6 months was observed in 43% (15/35) of patients. Six patients (17%) had a response duration of 12 months or longer.

Safety and Boxed Warnings

The FDA approved prescribing information contains boxed warnings for fatal/serious infection, diarrhoea or colitis, cutaneous reactions, and pneumonitis. The approved label includes warnings for neutropenia and hepatotoxicity.

Of the 442 patients with hematologic malignancies who received duvelisib at the approved dosing, 65% experienced serious adverse reactions (ARs), most commonly infection, diarrhoea or colitis, and pneumonia. Common ARs in ≥20% of patients include diarrhoea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection (URI), pneumonia, musculoskeletal pain, and anaemia. Permanent discontinuation of duvelisib due to ARs occurred in 35% of patients, and 24% of patients treated with duvelisib had a dose reduction.

Prescribing information Copiktra