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FDA Approves Ibrutinib for Mantle Cell Lymphoma

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Key Points

  • Ibrutinib (Imbruvica) was approved by the FDA for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
  • Efficacy results demonstrated an overall response rate of nearly 66%.
  • This is the second drug with Breakthrough Therapy designation to receive FDA approval.

The U.S. Food and Drug Administration today approved ibrutinib (Imbruvica) for the treatment of patients with mantle cell lymphoma, an aggressive B-cell lymphoma that represents about 6% of all non-Hodgkin lymphoma cases in the United States. The drug, a Bruton’s tyrosine kinase inhibitor, is intended to treat patients with mantle cell lymphoma who have received at least one prior therapy.

Ibrutinib is the second drug with Breakthrough Therapy designation to receive FDA approval following the passage of the Food and Drug Administration Safety and Innovation Act in July 2012, which allowed the FDA to expedite the development, review, and approval of a drug if preliminary clinical evidence indicates that it offers a substantial improvement over available therapies.

“[Ibrutinib’s] approval demonstrates the FDA’s commitment to making treatments available to patients with rare diseases,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Clinical Trial Results

Ibrutinib’s accelerated approval for mantle cell lymphoma is based on a study where 111 participants were given ibrutinib daily until their disease progressed or side effects became intolerable. The median duration of response was 17.5 months, and the efficacy results demonstrated an overall response rate of nearly 66%; 17% of patients achieved complete response and 49% achieved a partial response. An improvement in survival or disease-related symptoms has not been established.

The most common side effects reported in participants receiving ibrutinib are thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, edema, upper respiratory infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting, and decreased appetite. Other clinically significant side effects include bleeding, infections, kidney problems, and the development of other types of cancers.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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