FDA News

FDA approves Copiktra for leukemia, lymphoma subtypes

The FDA approved duvelisib for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies.

The agency also granted accelerated approval to duvelisib (Copiktra, Verastem Oncology) — an oral PI3K inhibitor — for patients with follicular lymphoma after at least two systemic therapies.

“Copiktra is an important addition to the evolving treatment paradigm for patients with CLL, small lymphocytic lymphoma [SLL] and follicular lymphoma,” Ian Flinn, MD, PhD, director of the lymphoma research program at Sarah Cannon Research Institute, said in a company-issued press release. “Copiktra is a significant addition to physicians’ treatment armamentarium that I believe will address an unmet need for patients who have limited options once they have progressed after two prior therapies.”

 

DUO trial
The FDA based the approval for patients with CLL or SLL on a subset of patients in the multicenter, open-label DUO trial. The full study included 312 patients with CLL and seven patients with SLL who received at least one prior therapy.

The analysis included 196 patients (median age was 69 years; 59% men) who received at least two prior therapies; 88% of these patients had an ECOG performance status of 0 or 1.

Researchers randomly assigned patients to receive duvelisib until disease progression or unacceptable toxicity or ofatumumab (Arzerra, Novartis) for seven cycles.

PFS assessed by an independent committee served as the primary endpoint.

Patients treated with duvelisib had median PFS of 16.4 months (standard error [SE], 2.1) compared with 9.1 months (SE, 0.5) among those treated with ofatumumab (HR = 0.4; SE, 0.2). Duvelisib-treated patients also had an increased overall response rate (78% vs. 39%).

 

DYNAMO trial

The FDA based the accelerated approval for follicular lymphoma on the single-arm, multicenter DYNAMO trial. The analysis included 83 patients (median age 64 years, 68% men, 37% with bulky disease) who were refractory to rituximab (Rituxan; Genentech, Biogen) and to either chemotherapy or radioimmunotherapy.

Exclusion criteria included grade 3b disease, large cell transformation, prior allogeneic transplant, and prior exposure to a PI3K inhibitor or to a Bruton tyrosine kinase inhibitor.

According to an independent review committee assessment, patients treated with duvelisib had an ORR of 42% (95% CI, 31-54), with one complete response and 34 partial responses.

Duration of response ranged from zero to 41.9 months.

The most common adverse events associated with duvelisib include diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain and anemia. The agent has a boxed warning for four fatal and serious toxicities — infections, diarrhea or colitis, cutaneous reactions and pneumonitis.

The FDA granted duvelisib fast track designation for CLL and follicular lymphoma, and orphan drug designation and priority review for CLL, SLL and follicular lymphoma.

“We are excited to offer a new treatment that can allow patients to manage their disease with an oral monotherapy,” Joseph Lobacki, executive vice president and chief commercial officer of Verastem Oncology, said in the release. “We continue to hear from physicians and patients that there is a great need for additional treatment options to fight chronic cancers such as CLL/SLL and follicular lymphoma.”

The FDA approved duvelisib for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies.

The agency also granted accelerated approval to duvelisib (Copiktra, Verastem Oncology) — an oral PI3K inhibitor — for patients with follicular lymphoma after at least two systemic therapies.

“Copiktra is an important addition to the evolving treatment paradigm for patients with CLL, small lymphocytic lymphoma [SLL] and follicular lymphoma,” Ian Flinn, MD, PhD, director of the lymphoma research program at Sarah Cannon Research Institute, said in a company-issued press release. “Copiktra is a significant addition to physicians’ treatment armamentarium that I believe will address an unmet need for patients who have limited options once they have progressed after two prior therapies.”

 

DUO trial
The FDA based the approval for patients with CLL or SLL on a subset of patients in the multicenter, open-label DUO trial. The full study included 312 patients with CLL and seven patients with SLL who received at least one prior therapy.

The analysis included 196 patients (median age was 69 years; 59% men) who received at least two prior therapies; 88% of these patients had an ECOG performance status of 0 or 1.

Researchers randomly assigned patients to receive duvelisib until disease progression or unacceptable toxicity or ofatumumab (Arzerra, Novartis) for seven cycles.

PFS assessed by an independent committee served as the primary endpoint.

Patients treated with duvelisib had median PFS of 16.4 months (standard error [SE], 2.1) compared with 9.1 months (SE, 0.5) among those treated with ofatumumab (HR = 0.4; SE, 0.2). Duvelisib-treated patients also had an increased overall response rate (78% vs. 39%).

 

DYNAMO trial

The FDA based the accelerated approval for follicular lymphoma on the single-arm, multicenter DYNAMO trial. The analysis included 83 patients (median age 64 years, 68% men, 37% with bulky disease) who were refractory to rituximab (Rituxan; Genentech, Biogen) and to either chemotherapy or radioimmunotherapy.

Exclusion criteria included grade 3b disease, large cell transformation, prior allogeneic transplant, and prior exposure to a PI3K inhibitor or to a Bruton tyrosine kinase inhibitor.

According to an independent review committee assessment, patients treated with duvelisib had an ORR of 42% (95% CI, 31-54), with one complete response and 34 partial responses.

Duration of response ranged from zero to 41.9 months.

The most common adverse events associated with duvelisib include diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain and anemia. The agent has a boxed warning for four fatal and serious toxicities — infections, diarrhea or colitis, cutaneous reactions and pneumonitis.

The FDA granted duvelisib fast track designation for CLL and follicular lymphoma, and orphan drug designation and priority review for CLL, SLL and follicular lymphoma.

“We are excited to offer a new treatment that can allow patients to manage their disease with an oral monotherapy,” Joseph Lobacki, executive vice president and chief commercial officer of Verastem Oncology, said in the release. “We continue to hear from physicians and patients that there is a great need for additional treatment options to fight chronic cancers such as CLL/SLL and follicular lymphoma.”