Duvelisib Indication in Relapsed/Refractory Follicular Lymphoma Withdrawn in U.S. Market

A United States indication for duvelisib in previously treated relapsed/refractory follicular lymphoma has been voluntarily withdrawn by developer Secura Bio following an assessment of the drug and subsequent consultation with the FDA.

Secura Bio has voluntarily withdrawn an indication for duvelisib (Copiktra) in the United States for the treatment of patients with relapsed/refractory follicular lymphoma who have undergone treatment with 2 prior therapies after assessing the drug and holding discussion with the FDA, according to a press release from the company.1

These measures highlighted that the cost, logistics, and timing of the post-marketing requirements were no longer merited. Duvelisib will continue to be developed for patients with T-cell lymphoma. In September 2018, duvelisib received accelerated approval by the FDA, but a confirmatory trial was required before it was given full approval. The decision to withdraw the indication does not affect other approved indications.

The initial approval was based on findings from the phase 3 DUO trial (NCT02004522) and the phase 2 DYNAMO trial (NCT01882803).2

In the DUO trial, 319 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) were given either duvelisib orally at 5 mg and 25 mg formulated capsules or ofatumumab (Arzerra) intravenously at 100 mg/5mL or 1000 mg/50mL. After patients received 18 cycles of duvelisib, patients were able to continue treatment until disease progression or unacceptable toxicity. Patients were not to exceed 12 doses of ofatumumab.

The median duration of exposure of duvelisib was 13 months versus 5 months for ofatumumab. The median progression-free survival was 16.4 months in duvelisib and 9.1 months in ofatumumab (HR, 0.40). Patients had an overall response rate of 78% in the duvelisib group compared with 39% in the ofatumumab group.

In the DYNAMO trial, 83 patients with indolent non-Hodgkin lymphoma were treated with 25 mg of duvelisib. Patients completed 13 cycles of treatment lasting 28 days each until disease progression or unacceptable toxicity. To receive additional treatment, patients were required to have evidence of a complete or partial response.

The median duration of exposure to duvelisib was 5 months. Duvelisib resulted in an ORR of 42%, with 1 patient achieving a complete response. Additionally, 34 patients achieved partial responses. The duration of response ranged from 0 to 41.9 months. 

The box warning indicates that serious infections occurred in 31% of patients, 4% of which were fatal. A total of 18% of patients also experienced serious/fatal diarrhea or colitis, with less than 1% of cases being fatal. Additionally, 5% of who had serious pneumonitis, with less than 1% of cases being fatal.

The most common adverse effects that occurred in more than 20% of patients was diarrhea or colitis, neutropenia, rash, fatigue, and pyrexia.

Duvelisib is a PI3K inhibitor, and the first FDA approved inhibitor to help support growth and survival of malignant cells. The current indication is for patients with relapsed/refractory CLL or SLL following 2 lines of treatment, and it has received fast track designation for peripheral T-cell lymphoma.

The company will be working with the FDA to revise the label, as well as notifying healthcare professionals about the current changes.


1. Secura Bio announces Copiktra® (duvelisib) strategic focus on T-cell lymphoma and voluntary U.S. withdrawal of the relapsed or refractory follicular lymphoma indication. News Release. Secura Bio. December 3, 2021. Accessed December 6, 2021. https://yhoo.it/3DuJb7c

2. Verastem Oncology receives FDA approval of COPIKTRA™ (duvelisib) capsules. News Release. Verastem Oncology. September 24, 2018. Accessed December 6, 2021. https://bit.ly/3GjQWic