FDA Approves Copiktra for CLL/SLL and Follicular Lymphoma

On September 24, 2018, the U.S. Food and Drug Administration (FDA) approved a new treatment for certain types of blood cancer: Copiktra (duvelisib). Manufactured by Verastem, Copiktra is approved to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have received at least two prior therapies. Copiktra is also approved to treat relapsed or refractory follicular lymphoma (FL) after at least two prior therapies. Due to the high response rate, Copiktra received an accelerated approval for FL.¹

A new option for relapsed and refractory blood cancer

Relapsed cancer describes a cancer that has come back after initial treatment. Refractory cancer is one that did not achieve a remission (the absence of symptoms or the absence of cancer cells in the blood). For people living with CLL, SLL, or FL that has relapsed or is considered refractory, Copiktra offers a new option to manage their disease and possibly extend their life.²

Efficacy in CLL/SLL

To evaluate the effectiveness of Copiktra in relapsed or refractory CLL and SLL, a clinical trial was conducted comparing Copiktra to Arzerra® (ofatumumab) with 196 patients who had previously received at least two systemic treatments. Patients were randomly assigned to receive one of the treatments: Copiktra is an oral treatment and was given twice daily, and Arzerra is a treatment administered intravenously (IV). The drugs were evaluated for their overall response rate (reducing or eliminating blood cancer cells) as well as the progression-free survival (the length of time when the blood cancer and its symptoms are kept from worsening, or the duration of remission).¹

The overall response rate was 78% for Copiktra and 39% for Arzerra (meaning 78% of patients who received Copiktra saw a reduction in their blood cancer). The median progression-free survival was also significantly higher in the patients who received Copiktra: 16.4 months compared to 9.1 months in the patients who received Arzerra.¹

Efficacy in FL

Copiktra was also evaluated in 83 patients with relapsed or refractory FL. In this trial, all patients were given Copiktra. The overall response rate was 42%, with 41% having a partial response and one patient having a complete response. Of those who had a response to Copiktra, 43% maintained that response for at least 6 months, and 17% maintained that response for at least 12 months. The FDA approval for FL may be dependent on another trial that compares Copiktra to another therapy.¹

Possible side effects

Copiktra may cause serious side effects, including serious or fatal infections, diarrhea or colitis (an inflammation of the intestines), rash, lung infections, liver damage, and lowered blood counts. Sixty-five percent of patients who received Copiktra in clinical trials experienced serious side effects, with the most common being infection, diarrhea or colitis, and pneumonia. Copiktra may also cause fatigue, fever, cough, nausea, upper respiratory infection, muscle or bone pain, and anemia. In some patients, the dose may be reduced or the medication may be discontinued due to the side effects.^1,3