The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Aliqopa (Ingredient: copanlisib) used in adults with relapsed follicular lymphoma who have received at least two prior systemic therapies, the agency said Thursday.
Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymphatic system. And it develops from B lymphocytes, a type of white blood cell of the lymphocyte subtype. Symptoms include flu-like symptoms and painless lumps in the neck, underarms, abdomen or groin.
Aliqopa is an intravenous pan-class I PI3K inhibitor that works by blocking several enzymes that promote cell growth. The drug received an accelerated approval after a single-arm trial that included 104 patients with follicular B-cell non-Hodgkin lymphoma, who had relapsed following at least two prior treatments.
The trial evaluated complete or partial shrinkage of the patient’s tumor, with 59 percent of patients showing complete or partial response for a median of 12.2 months.
However, Aliqopa can cause serious risks, including infections, hyperglycemia, hypertension, noninfectious pneumonitis, low levels of certain white blood cells neutropenia, severe skin reactions and can have fatal effects on developing fetus or newborn baby.
“For patients with relapsed follicular lymphoma, cancer often comes back even after multiple treatments,” an FDA official said. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them.”
<© Korea Biomedical Review, All rights reserved.>