FDA Approves Ibrutinib for Rare Type of NHL

Share this content:
The FDA has granted accelerated approval to ibrutinib (Imbruvica) for the treatment of patients with relapsed/refractory marginal zone lymphoma.
The FDA has granted accelerated approval to ibrutinib (Imbruvica) for the treatment of patients with relapsed/refractory marginal zone lymphoma.

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to ibrutinib (Imbruvica) for the treatment of patients with relapsed/refractory marginal zone lymphoma who require systemic therapy and have received at least 1 prior anti-CD20-based therapy.1

Approval in marginal zone lymphoma is based on findings from the multicenter, open-label, single-arm, phase 2 PCYC-1121 trial (ClinicalTrials.gov Identifier: NCT01980628), which assessed the efficacy and safety of ibrutinib in this patient population.

Among 63 patients with 3 subtypes of marginal zone lymphoma, 46% (95% CI, 33.4-59.1) achieved an overall response, including 3.2% who achieved a complete response and 42.9% who had partial response.

Median time to response was 4.5 months; the median duration of response was not reached.

The safety profile of ibrutinib in this study was consistent with previously reported safety data of ibrutinib in B-cell malignancies. The most frequently reported adverse events occurring in at least 20% of patients were thrombocytopenia, fatigue, anemia, diarrhea, bruising, musculoskeletal pain, hemorrhage, rash, nausea, peripheral edema, arthralgia, neutropenia, cough, dyspnea, and upper respiratory tract infection. The most common grade 3 to 4 adverse events were decreases in hemoglobin and neutrophils, as well as pneumonia.

RELATED: Venetoclax is Well Tolerated, Active in Non-Hodgkin Lymphoma

Ibrutinib is also indicated for patients with mantle cell lymphoma who have received at least 1 prior therapy, chronic lymphocytic leukemia/small lymphocytic lymphoma with or without 17p deletion, and Waldenström macroglobulinemia.

Reference

  1. U.S. FDA approves Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma (MZL) - a rare type of non-Hodgkin's lymphoma. Abbvie website. https://news.abbvie.com/news/us-fda-approves-imbruvica-ibrutinib-as-first-treatment-specifically-indicated-for-relapsedrefractory-marginal-zone-lymphoma-mzl--rare-type-non-hodgkins-lymphoma.htm. Published January 19, 2017. Accessed January 19, 2017.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters