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Catalent, Verastem Partner on Copiktra Capsules

10.17.18

FDA approves COPIKTRA capsules for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

Catalent’s partner, Verastem Oncology, received approval from the FDA for Copiktra (duvelisib) capsules, an oral inhibitor of phosphoinositide 3-kinase (PI3K), for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.
 
Copiktra also received accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Continued approval for this indication may be contingent on verification of clinical benefit in confirmatory trials.
 
Catalent has had a multi-year collaboration with Verastem, initially providing development and analytical support, and later clinical development and manufacturing services from its facility at Kansas City, MO.
 
“We are proud to partner with Verastem as part of the team delivering Copiktra capsules to patients. Catalent’s Kansas City facility is focused on oral and biologic programs, primarily with smaller pharmaceutical firms, to deliver products to patients with poorly met or unmet disease states,” said Matt Mollan, Catalent's general manager at Kansas City. “Like Verastem, Catalent is committed to advancing therapies with the potential to make a significant impact for patients, their caregivers and physicians. We look forward to building on this strong relationship through supplying clinical trial materials as well as commercial manufacturing and testing.”
 
Robert Forrester, president and chief executive officer of Verastem Oncology, added, “We selected Catalent as our development partner because of their experience and record of bringing similar therapies through clinical trials and on to successful commercialization. We are pleased to partner with Catalent in order to deliver this important new medicine to patients.”