Follicular lymphoma is one of the most common non-Hodgkin's lymphoma. The common symptom in patients is lymphadenopathy, which may cause fatigue, night sweats and weight loss. One of the hallmarks of this lymphoma is slow growth, and chemotherapy works well for this cancer. However, the patient's condition often relaps after remission, so patients with follicular lymphomas need to undergo regular screening and monitoring throughout their lives.
Today (September 15), the U.S. FDA (Merck.Accelerator) approves the listing of Aliqopa (copanlisib) from Bayer Healthcare Pharmaceuticals for the treatment of patients with recurrent follicular lymphoma, And has received at least two systemic therapies in adult patients. This is also the United States FDA approval of the first 10 this year, anti-cancer drugs .
Copanlisib, a new drug that is expected to make a difference in patients with follicular lymphoma, is a PI3K inhibitor. Copanlisib inhibits both PI3K-α and PI3K-δ kinase subtypes. In normal humans, PI3K-mediated signaling plays an important role in cell growth, survival and metabolism. Once the signal pathway out of control, it is easy to trigger non-Hodgkin's lymphoma. Therefore, the control of PI3K, is expected to control the development of lymphoma.
The trial enrolled 104 patients, all of whom had already received at least two treatments, but the disease still recurred. In the trial, patients treated with copanlisib objective response rate reached 59%, bringing a significant improvement in patients' lives. Based on the excellent data from this clinical trial, the FDA awarded the new drug priority review status.
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