This week the Food and Drug Administration (FDA) has approved Imbruvica® (ibrutinib) for use in Marginal Zone Lymphoma (MZL) patients. Imbruvica® is a Bruton’s Tyrosine Kinase (BTK) targeting therapy that already has approval in other lymphoma subtypes such as CLL and WM. The newly approved indication for Imbruvica® is in R/R MZL patients who require systemic therapy having already received at least one anti-CD20-based therapy, and marks the first approved treatment in relapsed/refractory MZL. The accelerated approval in MZL means the approval is conditional upon continued study results and further trial data.
The accelerated approval comes after the results of the PCYC-1121 trial (NCT01980628), which were reported by Ariela Noy during the American Society of Hematology Annual Meeting 2016, where the Lymphoma Hub interviewed Stefano Luminari on the oral presentation. The PCYC-1121 study of Imbruvica® treatment in 63 MZL patients reported an overall response rate of 46% (95% CI: 33.4–59.1), with 42.9% achieving partial recovery and 3.2% achieving complete recovery.
IMBRUVICA® (Ibrutinib) Approved by FDA For Marginal Zone Lymphoma (MZL) Patients Who Require Systemic Therapy and Have Received At Least One Prior Anti-CD20-Based Therapy. 2017 Jan 19.http://www.biospace.com/News/janssen-biotech-release-imbruvica-ibrutinib/444570. [Accessed 20/01/17].
Noy A. et al. Single-Agent Ibrutinib Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Phase 2 Study. 2016 December 5; Oral Abstract #1213: ASH 58th Annual Meeting and Exposition, San Diego, CA.