Posted from: Monday, October 08, 2018 - 12:44 PM - Present

Copiktra Approved to Treat Lymphoma and Leukemia

September 24, 2018 – The U.S. FDA has approved Copiktra™ (duvelisib), manufactured by Verastem Oncology, 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 also received approval to treat relapsed or refractory follicular lymphoma (FL) in patients who have undergone treatment with at least two prior systemic therapies.

CLL, SLL, and FL are indolent forms of non-Hodgkin lymphoma (NHL). Indolent lymphomas grow and spread slowly, often without the patient exhibiting symptoms. CLL, SLL, and FL account for a combined 350,000 cases out of a total 681,000 individuals diagnosed with NHL in the United States.

Patients diagnosed with CLL, SLL, or FL may experience periods of remission followed by relapse. Refractory SLL, CLL, and FL no longer respond to therapy. In clinical trials, patients with relapsed or refractory CLL or SLL experienced a mean progression free survival (PFS) time of 16.4 months with an overall response rate (ORR) of 78% on Copiktra, versus 9.1 months on ofatumumab (39% ORR). Patients diagnosed with FL had an ORR of 42% on Copiktra, with 43% of patients experiencing a durability of response that lasted for at least six months. The FL indication is approved under the FDA’s accelerated approval program, with full approval contingent upon the results of further study.

Copiktra’s recommended dosing under all indications is 25mg taken by mouth twice per day. A black box warning cautions that the drug may put patients at risk of fatal and/or serious infections, diarrhea and colitis (inflammation of the large intestine), cutaneous (skin) reactions, and pneumonitis (an inflammatory lung condition). As a result, Verastem has implemented an informational Risk Evaluation and Mitigation Strategy (REMS) to assist in appropriate prescribing.

Verastem launched Copiktra immediately upon approval at a wholesale acquisition cost (WAC) of $11,800 per month.

 

Last Updated Friday, October 19, 2018 - 08:13 PM.