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Verastem Oncology's Copiktra for lymphoma gets FDA nod

Verastem Oncology has received clearance from the Food and Drug Administration for Copiktra (duvelisib) capsules, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma.

Copiktra is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. Lymphoma is the most common blood cancer, and CLL/SLL and FL are common types of indolent non-Hodgkin lymphomas (iNHL).

Copiktra also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

“With today’s FDA approval of Copiktra, Verastem Oncology is delivering upon our commitment to patients with cancer by bringing a new oral medicine to market,” Verastem Oncology’s president and CEO Robert Forrester said. “We are pleased to be able to introduce Copiktra during National Blood Cancer Awareness Month. At Verastem Oncology, we are driven by the strength and courage of those battling cancer, and we are committed to advancing therapies such as Copiktra with the potential to make a significant impact for patients, their caregivers and physicians. We are immensely grateful to the many patients who participated in the duvelisib clinical trial program over the years leading to this pivotal moment.”

“Copiktra is an important addition to the evolving treatment paradigm for patients with CLL/SLL and FL,” Ian Flinn, director of the Lymphoma Research Program at Sarah Cannon Research Institute and lead investigator of the Dynamo and Duo studies said in a statement. “The approval of Copiktra for the treatment of relapsed or refractory CLL/SLL after at least two prior therapies, or relapsed or refractory FL after at least two prior systemic therapies, is based on clinical trial data gathered from the treatment of over 400 adult patients. 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.”

“Patients living with CLL/SLL or FL are in need of additional treatment options, and new therapies such as Copiktra are crucial because each patient’s treatment journey is unique,” Lymphoma Research Foundation CEO Meghan Gutierrez said. “We appreciate the commitment from companies like Verastem Oncology that research and develop these therapies with the goal of reaching a day when lymphoma is managed as a chronic disease — and eventually cured.”
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