US FDA approves AbbVie’s Imbruvica to treat marginal zone lymphoma

The US Food and Drug Administration (FDA) has approved AbbVie’s Imbruvica (ibrutinib) for the treatment of patients with relapsed / refractory (R/R) marginal zone lymphoma (MZL).

The indication is approved under accelerated approval, which is based on overall response rate (ORR).

Pharmacyclics, an AbbVie company, and Janssen Biotech have jointly developed and commercialised Imbruvica.

Pharmacyclics early development and immunotherapy head Darrin Beaupre said: "The FDA approval of imbruvica for relapsed / refractory marginal zone lymphoma is significant, and we are proud of the culmination of this extensive clinical research programme, representing the first approved treatment specifically for patients with this rare type of non-Hodgkin's lymphoma.

"This milestone marks the fifth patient population for whom imbruvica is now approved and broadens the number of patients who may be treated with the medication."

The approval in MZL is based on data from the Phase II single-arm PCYC-1121 study, which evaluated the safety of the indication in MZL patients.

Memorial Sloan Kettering Cancer Center hematologic oncologist Ariela Noy said: "In the Phase II trial, imbruvica demonstrated impressive response rates and duration of response in relapsed / refractory marginal zone lymphoma patients.

"The haematology-oncology community welcomes a new option like imbruvica, which helps fill a significant treatment gap for previously treated MZL patients who are in need of non-chemotherapy options."

Imbruvica is now approved for the treatment of patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.

The slow-growing B-cell lymphoma MZL arises from white blood cells (lymphocytes) at the edges of lymphoid tissue.