FDA Approves Aliqopa for Adults with Relapsed Follicular Lymphoma

From Drugs.com - September 14, 2017

FDA Approves Aliqopa

FDA Approves Aliqopa (copanlisib) for Adults with Relapsed Follicular Lymphoma

September 14, 2017 -- The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments, said Richard Pazdur, M.D., director of the FDAs Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDAs Center for Drug Evaluation and Research. Options are limited for these patients and todays approval provides an additional choice for treatment, filling an unmet need for them.

Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymph system. The lymph system is part of the bodys immune system and is made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils and bone marrow. The National Cancer Institute at the National Insititutes of Health estimates that approximately 72,240 people in the United States will be diagnosed with some form of non-Hodgkin lymphoma this year; approximately 20,140 patients with non-Hodgkin lymphoma will die from the disease in 2017.

Aliqopa is a kinase inhibitor that works by blocking several enzymes that promote cell growth.

Aliqopa received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Aliqopas clinical benefit and the sponsor is currently conducting these studies.

Todays approval of Aliqopa was based on data from a single-arm trial that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 59 percent of patients had a complete or partial response for a median 12.2 months.

Common side effects of Aliqopa include high blood sugar levels (hyperglycemia), diarrhea, decreased general strength and energy, high blood pressure (hypertension), low levels of certain white blood cells (leukopenia, neutropenia), nausea, lower respiratory tract infections, and low levels of blood platelets (thrombocytopenia).

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