Drugs/Therapy

Marginal Zone Lymphoma: FDA Approves First Drug For This Rare Form Of Non-Hodgkin's Lymphoma

By Beatrix Smith | Update Date: Jan 22, 2017 10:29 PM EST

The U.S. Food and Drug Administration (FDA) has granted the green light to Imbruvica (Ibrutinib) for the treatment of patients with marginal zone lymphoma (MZL), a rare form of non-Hodgkin's lymphoma and a low-grade form of lymphoma.

Developed by AbbVie, a biopharmaceutical company, the drug will be utilized for the treatment of patients with relapsed forms of the disease who have received one anti-CD20-based therapy in the past and are required to have a systemic therapy.

"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," Dr. Darrin Beaupre, said in a press release.

The researchers of the study and clinical trial are continuing to examine the drug across many other diseases, including B-cell malignancies.

Efficacy Of Imbruvica

The FDA's approval came after the results of Phase II PCYC-1121 study came out and showed that the overall response rate for the drug was attained in 46 percent of the patients. Moreover, the effectiveness of the drug was seen across all three MZL subtypes tested.

The investigators of the clinical trial have found that the complete response rate is 3.2 percent and the median progression-free survival was 14.2 months.

Imbruvica (Ibrutinib) has also been approved by the FDA to treat mantle cell lymphoma, small lymphocytic lymphoma, chronic lymphocytic leukemia and Waldenström's macroglobulinemia over the past years.

What Is Marginal Zone Lymphoma?

Lymphoma is the most common type of blood cancer divided into two types - Hodgkin and non-Hodgkin lymphoma, according to the Lymphoma Research Foundation. Marginal Zone Lymphoma is a slow-growing B-cell lymphoma coming from the white blood cells (lymphocytes) at the edges of the lymphoid tissue. This type of lymphoma account for about 12 percent of all B-lymphomas.

Low-grade lymphomas, such as MZL, can be hard to clear completely. However, these can be kept under control for many years.

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