NOVIEMBRE 21, 2019
FDA Approves Acalabrutinib for Patients With CLL, SLL
The US Food and Drug Administration (FDA) has granted supplemental approval to acalabrutinib (Calquence) for the treatment of adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
This new approved indication for acalabrutinib provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.
“Today, as part of a US, Australian, and Canadian collaboration known as Project Orbis, the US approved a new treatment option for those living with CLL or SLL,” said Richard Pazdur, MD, FDA Center for Drug Evaluation and Research, Rockville, Maryland. “The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners. We are pleased to continue working alongside our Australian and Canadian colleagues to facilitate new treatment options for patients and the FDA looks forward to working with other countries in future application reviews.”
The supplemental approval of acalabrutinib for patients with CLL or SLL was based on 2 randomised clinical trials that compared acalabrutinib with other standard treatments. The first clinical trial involved 535 patients with previously untreated CLL. Patients receiving acalabrutinib had a longer progression-free survival compared with patients receiving other standard treatments. The second clinical trial included 310 patients with previously treated CLL. Patients receiving acalabrutinib also had a longer progression-free survival than patients receiving other standard treatments.
The most common side effects of acalabrutinib were anaemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhoea, and musculoskeletal pain.
Patients may experience atrial fibrillation and flutter and should be monitored for symptoms of arrhythmias. Patients may also experience serious infections and should be monitored and treated promptly. Those taking acalabrutinib should be monitored for bleeding and managed appropriately. Patients may also experience low blood counts and should have blood work monitored regularly.
Patients should be advised to use sun protection as other malignancies, such as skin cancers and other solid tumours, have occurred in patients taking acalabrutinib.
The FDA advises healthcare professionals to tell females of reproductive age to use effective contraception during treatment with acalabrutinib. Women who are pregnant or breastfeeding should not take acalabrutinib because it may cause harm to a developing fetus or newborn baby, or cause delivery complications.
In addition to the international collaboration with Australia and Canada, this review used the Real-Time Oncology Review (RTOR) pilot program, which can streamline the submission of data prior to the completion and submission of the entire clinical application. RTOR, and its accompanying Assessment Aid, facilitated discussions among the regulatory agencies. These applications were approved 4 months prior to the FDA goal date.
The FDA granted this application Priority Review and Breakthrough Therapy designation.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
SOURCE: US Food and Drug Administration
UN VIAJE A TRAVES DE LA HEMATOLOGIA 