A new treatment will soon be available for adults with relapsed follicular lymphoma, a slow-growing form of non-Hodgkin lymphoma, following the U.S. Food and Drug Administration's (FDA) approval of Aliqopa (copanlisib). The drug was granted Accelerated Approval as it fills an unmet medical need. Further trials are required and underway to confirm the clinical benefits of the drug.
Aliqopa's approval was based on data from a single-arm trial of 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease after at least two earlier treatments. The trial showed nearly six out of ten (50 percent) of patients had a complete or partial response to the drug for a median of more than one year.
The medication developed by Bayer Healthcare Pharmaceuticals is a kinase inhibitor that slows and stops the growth of cancerous cells by blocking a number of enzymes that promote cell growth. It was granted Priority Review status, which means the FDA aims to take action on the application within six months. Aliqopa also received Orphan Drug designation, which provides pharmaceutical firms with added incentives to develop medicine to treat rare diseases.
Richard Pazdur MD, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained patients with relapsed follicular lymphoma often see the cancer returning, even after a number of treatments.
"Options are limited for these patients and today's approval provides an additional choice for treatment, filling an unmet need for them," he asserted.
Non-Hodgkin lymphoma is more common in older patients. Estimates from the National Cancer Institute at the National Institutes of Health forecast more than 72,000 new cases will be diagnosed in the United States this year. Among the drugs used to treat non-Hodgkin lymphoma is Rituxan (rituximab), one of the top-selling Orphan Drugs of 2016 by sales, according to the EvaluatePharma Orphan Drug Report 2017.