The U.S. Food and Drug Administration (FDA) granted accelerated approval to Aliqopa® (copanlisib), a novel precision cancer medicine that inhibits phosphatidylinositol 3-kinase (PI3K), for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.
Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin’s lymphoma (NHL), which is a type of cancer originating in immune cells referred to as B-cells. Follicular lymphoma accounts for approximately one in five cases of NHL, and is considered incurable with standard treatment options. In the United States, it is estimated that more than 14,000 new cases of follicular lymphoma will be diagnosed in 2017.
About Aliqopa (copanlisib)
Aliqopa is a precision cancer medicine that inhibits several key cell-signaling pathways in lymphoma cell lines resulting in cancer cell death by apoptosis and inhibition of the growth of primary malignant B cell lymphoma cell lines.
The current FDA approval of Aliqopa was based on the results of the phase CHRONOS-1 clinical trial. The CHRONOS-1 study treated 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed after at least two prior treatments with Aliqopa 60 mg intravenously on days 1, 8, and 15 of a 28-day cycle.
Overall the therapy was well tolerated, and 61 patients responded to treatment, with 15 patients (14%) achieving a complete response, for an overall response rate of 59%, and a median duration of response of 12.2 months with some patients with sustained responses greater than 22 months.
Copanlisib was previously granted priority review and orphan-drug designation.
Reference: FDA press release, September 14, 2017; Bayer press release, September 14, 2017.
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