FDA to Review Imbruvica for Rare Lymphoma Indication
Janssen announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib; Janssen and Pharmacyclics) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy. If approved, Imbruvica will be the first treatment approved for patients with MZL.
The sNDA filing was based on data from the PCYC-1121 trial (n=63), a Phase 2 multicenter, open-label study that evaluated the use of ibrutinib in patients with MZL who received at least 1 prior therapy, including splenic MZL, nodal MZL, and extranodal MZL. Patients received ibrutinib 560mg once daily until progression or unacceptable toxicity. The primary endpoint was overall response rate as assessed by an Independent Review Committee. Major secondary endpoints included duration of response and overall response rate.
Ibrutinib a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, is already indicated to treat mantle cell lymphoma (MCL) in patients who have received at least one prior therapy; chronic lymphocytic leukemia (CLL); CLL in patients with 17p deletion; and Waldenstrom's macroglobulinemia (WM).
Imbruvica is available as 140mg strength capsules.