This Company Just Withdrew Two of Its Drug Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma

According to a story from BioPharma Dive, the drug company AbbVie has recently announced its decision to withdraw two different approvals for its cancer therapy Imbruvica. The approvals were withdrawn for marginal zone lymphoma and mantle cell lymphoma following trials in which the therapy failed to confer the benefits projected in earlier tests. While Imbruvica is perhaps most widely used for more common cancers, such as chronic lymphocytic leukemia, the decision also removes the drug’s first-ever approval in 2013 for mantle cell lymphoma in patients that had been treated with one other medication.

About Mantle Cell Lymphoma

Mantle cell lymphoma is a rare type of non-Hodgkin’s lymphoma. There are only about 15,000 patients in the US. This blood cancer affects B-cells, a type of white blood cell. The risk factors for mantle cell lymphoma are not particularly well known; however, acquired genetic mutations in the affected cells are what eventually causes them to become malignant. Most patients are diagnosed in their 60s. In many cases, the disease is not diagnosed until it has reached an advanced stage. Symptoms include fever, night sweats, enlarged spleen and lymph nodes, and weight loss. Treatment options include immunotherapy, chemotherapy, and targeted therapies. Mantle cell lymphoma often relapses after treatment with chemotherapy. Prognosis is difficult to predict; the five-year survival rate is 50 percent, but this figure improves to 70 percent with limited-stage disease. To learn more about mantle cell lymphoma, click here.

About Marginal Zone Lymphoma

Marginal zone B-cell lymphoma, often shortened to marginal zone lymphoma, is a rare type of non-Hodgkin’s lymphoma. This is a slow growing form of lymphoma, and they comprise around 12 percent of all non-Hodgkin’s lymphoma cases. As the name implies, this type of lymphoma affects B-cells in the “marginal zones” of different areas of the body. The direct cause of marginal zone lymphoma remains unknown, but a number of risk factors have been identified, such as being more than 60 years old, infectious with the hepatitis C virus, prior history of chronic inflammation or autoimmune conditions, malaria, lupus, and Sjogren syndrome. The symptoms vary depending on the type of marginal zone lymphoma, which are distinguished by the location of malignant activity. They may include lymph node swelling, night sweats, fever, fatigue, weight loss, spleen enlargement, nausea, vomiting, cough, red eyes, shortness of breath, and problems swallowing. Treatment includes chemotherapy, radiation, and immunotherapy. To learn more about marginal zone lymphoma, click here.

Accelerated Approval

It’s worth noting that this first approval, along with the approval for marginal zone lymphoma, were under Accelerated Approval protocols, meaning that confirmatory trials were necessary in order to gain permanent acceptance from the US Food and Drug Administration (FDA).

The follow up study in mantle cell lymphoma saw a combination of Imbruvica and chemotherapy achieve the primary endpoint of slowing tumor progression; however, the regimen was linked to more high-grade adverse events and didn’t extend survival. The marginal zone lymphoma trial saw no success at all.

The decision follows a string of companies that have withdrawn Accelerated Approvals after failed confirmatory trials.

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