g 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.1 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.
Aliqopa will be available in the U.S. market immediately. The Aliqopa™ Resource Connections (ARCTM) Program, which is dedicated to supporting patients on their treatment journey and includes a range of resources to help navigate the insurance process and identify sources of financial assistance, is now available. The program offers free medication to those who are uninsured or underinsured and meet the eligibility criteria, and includes a $0 Co-Pay Program for covered patients. For more information, visit www.aliqopa.com.
Efficacy and Safety Data Supporting Aliqopa Approval
The Phase II CHRONOS-1 (ClinicalTrials.gov Identifier: NCT01660451) trial included 104 subjects with follicular B-cell NHL who had relapsed disease following at least two prior systemic therapies.1 In the trial, copanlisib achieved an ORR of 59% [n=104 (95% CI 49, 68)], with 14% of patients achieving a complete response, and a median duration of response of 12.2 months (0+, 22.6).1 Tumor response was assessed according to the International Working Group response criteria for malignant lymphoma. |
