AbbVie to withdraw in the U.S., accelerated Imbruvica approvals for patients with the blood cancers mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL)
AbbVie announced the intent to voluntarily withdraw, in the U.S., accelerated Imbruvica (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma (MCL) who have received at least one prior therapy and with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
AbbVie announced the intent to voluntarily withdraw, in the U.S., accelerated Imbruvica (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma (MCL) who have received at least one prior therapy and with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Other approved indications for Imbruvica in the U.S. are not affected.
This voluntary action is due to requirements related to the accelerated approval status granted by the FDA for MCL and MZL. These indications were approved via this pathway based on overall response rates in Phase II clinical studies. To confirm clinical benefit following accelerated approvals, additional studies are required by the FDA.
The Phase III SHINE (NCT01776840) study in previously untreated MCL and the Phase III SELENE study (NCT01974440) in relapsed or refractory MZL served as confirmatory studies. The SHINE study met its primary endpoint of progression-free survival. The addition of Imbruvica to chemoimmunotherapy was associated with increased adverse reactions compared to the placebo-controlled arm. The SHINE study results were presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and were published in The New England Journal of Medicine. The SELENE study did not meet its primary endpoint of progression-free survival. The SELENE study results will be presented at a future scientific forum.
Imbruvica's established clinical profile in other approved indications is unchanged and the medication remains the most comprehensively studied and prescribed cancer treatment in its class. Imbruvica remains an important therapy for patients and healthcare professionals around the world.
See "Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma":Michael L. Wang, M.D., Wojciech Jurczak, M.D., Ph.D. et al.-June 30, 2022 N Engl J Med 2022; 386:2482-2494 DOI: 10.1056/NEJMoa2201817.
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