Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Aliqopa (copanlisib) for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on ORR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Aliqopa is a novel intravenous PI3K inhibitor with inhibitory activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. The FDA granted approval under the accelerated approval pathway based on data from the open-label, single-arm Phase II CHRONOS-1 trial investigating Aliqopa in 104 adult patients with follicular B-cell non-Hodgkin’s lymphoma (NHL) who had relapsed disease following at least two prior systemic therapies.
FL is the most common subtype of indolent, or slow-growing, NHL, comprising approximately one out of five lymphomas in the U.S. Response rates and duration of response decline with each line of therapy, underscoring the need for patients whose disease has already progressed.
“Before the approval of Aliqopa, doctors and patients facing follicular lymphoma, a very serious and difficult-to-treat blood cancer, have had a need for new and effective options when patients relapse,” said Carsten Brunn, Head of Bayer Pharmaceuticals, Americas Region. “The FDA’s accelerated approval of this important treatment reflects Bayer’s commitment to delivering new treatment options, and we commend the FDA on its speedy review and ongoing dedication to innovation in areas of great unmet medical need.”
“When treating patients with relapsed follicular lymphoma, two factors for physicians involve lessening tumor burden and reducing adverse events patients may experience from treatments. Therapies need to be both effective and tolerable,” said Dr. Anas Younes, Medical Oncologist and Chief of Lymphoma Service at Memorial Sloan Kettering Cancer Center. “The PI3K pathway is activated in many tumor types, including lymphoma, and targeting PI3K therapeutically is a very important strategy in this area of disease. Copanlisib has a safety and efficacy profile that is a welcome advance for both doctors and patients in third-line follicular lymphoma.”
Aliqopa is associated with the following Warnings and Precautions: serious, including fatal, infections, Grade 3 or 4 hyperglycemia, Grade 3 hypertension, non-infectious pneumonitis (NIP), Grade 3 or 4 neutropenia, Grade 3 or 4 cutaneous reactions, and embryo-fetal toxicity. Please see the full Important Safety Information below.
Developed by Bayer, Aliqopa is the only approved PI3K inhibitor with inhibitory activity predominantly against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. It is also the only one to be administered intravenously on an intermittent schedule.
“Today’s approval of copanlisib marks an important advance in the development of new treatment options for adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “This approval provides another option for patients; we commend the patients and investigators who enable research such as this to continue to push forward to ultimately move closer to finding a cure.”
The New Drug Application for Aliqopa received priority review, which is reserved for medicines that would provide significant improvements in the safety or effectiveness of the treatment of serious conditions. The product was approved under FDA regulations 21 CFR Part 314 Subpart H (accelerated approval). The FDA had previously granted Aliqopa fast track designation in FL as well as Orphan Drug designation for the treatment of patients with FL and for the treatment of splenic, nodal, and extranodal subtypes of marginal zone lymphoma.
