Janssen Research & Development, LLC (Janssen) today announced patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the United States for the investigational oral Bruton's Tyrosine Kinase (BTK) inhibitor ibrutinib, which is being jointly developed by Janssen and Pharmacyclics, Inc. Several EAP sites are in the process of opening the clinical trial and information about the program is posted on clinicaltrials.gov (NCT01833039). The mantle cell lymphoma (MCL) EAP is available to eligible patients with relapsed or refractory MCL, who could benefit from treatment with ibrutinib prior to U.S. Food and Drug Administration (FDA) approval.
Interested patients with MCL should discuss the option of accessing ibrutinib through the EAP with their physician to understand if this is an appropriate option for them.
"We recognize there are immediate medical needs of certain individuals with relapsed or refractory MCL," said Peter F. Lebowitz , M.D., Ph.D., Global Oncology Head, Janssen. "Now that the ongoing U.S. clinical studies in relapsed or refractory MCL have completed enrollment, the expanded access protocol provides that opportunity."
The ibrutinib expanded access program was agreed upon in collaboration with the FDA as part of ibrutinib's breakthrough therapy designation for relapsed/refractory MCL granted by the FDA in February 2013. EAPs are allowed by the FDA under certain circumstances even though the safety and effectiveness of the drug have not been fully established. Expanded access programs provide a mechanism for early access to an investigational drug in the pre-approval period to treat patients with a serious or immediately life-threatening disease or condition that has no comparable or satisfactory alternative treatment options.
Janssen Research & Development, LLC