Catalent Pharma Solutions has partnered with Verastem Oncology for development and delivery of Copiktra (duvelisib) capsules, Verastem’s first new product approved recently by the U.S. Food and Drug Administration.
Copiktra is an oral inhibitor of phosphoinositide 3-kinase (PI3K) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. The drug also received accelerated approval for the treatment of adults with relapsed or refractory follicular lymphoma after at least two prior systemic therapies, with continued approval subject to verification and clinical benefit in confirmatory trials.
Catalent has had a multi-year collaboration with Verastem Oncology, initially providing development and analytical support, and later clinical development and manufacturing services from its Kansas City facility, which is focused on oral and biologic programs, primarily with smaller pharmaceutical firms.
The 450,000 square-foot Catalent facility provides a range of support services, from formulation development and analytical testing, to clinical- and commercial-scale manufacturing and packaging of various oral dose forms.
“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,” Robert Forrester, president and CEO of Verastem, said.
CLL/SLL mostly affects elderly patients and many are unable or unwilling to be hospitalized or come into the clinic for frequent IV infusions, Diep Le, M.D., Ph.D., Verastem chief medical officer, said in December discussing Phase III duvelisib trial results. He added that the CLL/SLL treatment landscape is moving away from chemotherapies and toward more targeted, preferably oral regimens.
Copiktra will be available in the U.S. market immediately, according to the company.